Safety

Human Drug Product Recalls Pending Classification

FDA is conducting a pilot program seeking to expedite notifications of human drug product recalls to the public. In addition to the information about classified recalls found in the weekly Enforcement Report, the agency will include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. The information will be continue to be provided in a narrative format until FDA has decided upon the method to include it in the new Enforcement Report format.  They will be reposted with their classification in the Enforcement Report once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov. 
 
 
  • Pending Recalls for the November 12, 2014 Enforcement Report

 

PRODUCT:
Losartan Potassium Tablets USP, 25 mg, 1000 Tablet Bottles, NDC 42571-110-10
CODE:
Lot #LJAG003, Expiry: 05/2015
RECALLING FIRM:
Micro Labs USA, Inc. Princeton, NJ 08540
REASON FOR RECALL:
Failed Content Uniformity Specifications; Dry mix failed specifications.
 
  • Pending Recalls for the October 22, 2014 Enforcement Report

 

PRODUCT
TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL and 1 vial of 2.2 mL DILUENT per carton, Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101; Diluent Made in Italy, NDC 0008-1179-01.
CODE
Kit Lot #: AIEM/13, Exp 05/16 that contain diluent lots AHZW/11 and AHZW/12
RECALLING FIRM
Pfizer Inc., New York, NY
REASON FOR RECALL
Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The TORISEL vials are not affected by this issue.
 
  •  Pending Recalls for the September 17, 2014 Enforcement Report

 

PRODUCT:
Buprenorphine Hydrochloride Inj. 0.3 mg base/mL packaged as 1 mL in a 2.5 mL Carpuject sterile cartridge unit with luer lock for IV or IM Use. NDC 00409-2012-32
CODE:
Lot #s:  35730LL, 35745LL, Exp 1 FEB 2015
RECALLING FIRM:
Hospira, Inc., 275 N Field Dr., Lake Forest, IL 60045
REASON FOR RECALL:
Failed Impurities/Degradation Specifications
 
PRODUCT:
Fluocinonide Gel USP, 0.05%, 15 gram (NDC 0168-0135-15) and 60 g (NDC 0168-0135-60) tubes
CODE:
15 gram lot #s: 549N, 550N, 551N, Exp. 1/31/2015, EB1961, Exp. 2/28/2017
60 gram lot #s: 546N, 547N, 548N, Exp. 1/31/2015, EB0144, Exp. 2/28/2017
RECALLING FIRM:
Fougera Pharmaceuticals Inc., 60 Baylis Rd, Melville New York 11747-3838
REASON FOR RECALL:
Failed Stability Specifications: The lots may not meet the USP requirement for residual solvents

 

 

  • Pending Recalls for the September 10, 2014 Enforcement Report

 

 

PRODUCT
CHIROTHIN Liquid Dietary Supplement, 2 Fl Oz (60 ml) bottles
CODE
Lot #: 072010-22, Exp: 12/2013; Lot #: 072010-23, Exp: 01/2014; Lot #: 072010-25, Exp: 03/2014; Lot #: 072010-26, Exp: 04/2014; Lot #: 072010-27, Exp: 05/2014; Lot #: 072010-29, Exp: 07/2014; Lot #: 072010-30, Exp: 08/2014; Lot #: 072010-31, Exp: 09/2014; Lot #: 072010-33, Exp: 11/2014; Lot #: 072010-34, Exp: 01/2015; Lot #: 072010-36, Exp: 02/2015; Lot #: 072010-39, Exp: 05/2015; Lot #: 072010-43, Exp: 06/2015; and Lot #: 072010-48, Exp: 10/2015.
RECALLING FIRM
ChiroNeutraceutical, Chesterfield, MO
REASON FOR RECALL
Marketed without an Approved NDA/ANDA: Product contains undeclared hHCG
 
 
PRODUCT
Oxycodone and Acetaminophen Tablets USP 10mg/325 mg, Rx only, NDC 4778123001
CODE
Lot # 453289
RECALLING FIRM
Alvogen, Inc., Pine Brook, NJ
REASON FOR RECALL
Failed Content Uniformity Specifications
 
 
PRODUCT
Oxycodone and Acetaminophen Tablets USP 10mg/325 mg, 100 count bottles, Rx only, NDC 4778-1230-01
CODE
Lot # 453289, Exp 8/31/2015
RECALLING FIRM
Alvogen, Inc., Pine Brook, NJ
REASON FOR RECALL
Failed Content Uniformity Specifications
 
 
 
  • Pending Recalls for the September 2, 2014 Enforcement Report

 

PRODUCT
Warfarin Sodium Tablets, USP Crystalline, 2 mg, Rx only, 1) 100 Tablet Bottle (NDC: 51672-4028-1); 2) 1000 Tablet Bottle (NDC: 51672-4028-3)..
CODE
Lot #: 149400, Expiry: January 2016; Lot #: 149649, Expiry: January 2016.
RECALLING FIRM
Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY
REASON FOR RECALL
Failed Content Uniformity Specifications
 
  • Pending Recalls for the August 13, 2014 Enforcement Report

 

PRODUCT
Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx Only.
CODE
Lot # 2004069, Expiry: 09/2014; Lot #: 2004070, Expiry: 09/2014.
RECALLING FIRM
Mylan Pharmaceuticals, Inc., Morgantown, WV
REASON FOR RECALL
Failed Impurities/Degradation Specifications; Out of Specification for Total Impurities and Lactol.
 
 
PRODUCT
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05.
CODE
Lot #: C940700, C940841, Exp 05/16
RECALLING FIRM
Baxter Healthcare Corporation, Deerfield, IL
REASON FOR RECALL
Presence of Particulate Matter: particulate matter was found during the manufacturing process.
 
 
  • Pending Recalls for the July 30, 2014 Enforcement Report
PRODUCT
THINOGENICS CAPSULES, 30 Count Bottles
CODE
None; All product distributed prior to 2/6/2014
RECALLING FIRM
Nature’s Universe, Nashville, TN
REASON FOR RECALL:
Marketed Without an Approved NDA/ANDA; Contains undeclared sibutramine.
 
PRODUCT
1)      Azor (amlodipine and olmesartan medoximil) tablets, 10mg/40 mg, 30 count, Rx only, NDC 65597-110-30
2)      Benicar (olmesartan medoximil) tablets, 20 mg, 30 & 90 count, Rx only, NDC 65597-103-30
3)      Benicar (olmesartan medoximil) tablets, 40 mg, 30 & 90 count, Rx only, NDC 65597-104-30
4)      Benicar HCT (olmesartan medoximil and hydrochlorothiazide) tablets, 20 mg/12.5 mg, 30 count, NDC 65597-105-30
5)      Benicar HCT (olmesartan medoximil and hydrochlorothiazide) tablets, 40 mg/12.5 mg, 30 count, NDC 65597-106-30
6)      Benicar HCT (olmesartan medoximil and hydrochlorothiazide) tablets, 40 mg/25 mg, 30 & 90 count Tablets, NDC 65597-107-30
7)      Tribenzor (olmesartan medoximil, amlodipine, hydrochlorothiazide) tablets, 40/5/25 mg, 30 count, Rx only, NDC 65597-116-30
8)      Welchol (colesevelam HCl) tablets, 625 mg, 180 count, NDC 65597-701-18
CODE
1)      Lot #213655B
2)      30 count Lot #0002055 Exp - 11/30/2016, 90 count Lot #0002063 Exp - 12/31/2016
3)      30 count Lot #0002096 Exp - 12/31/2016, 90 count Lot #0002058 Exp -12/31/2016
4)      30 count Lot #0002106 Exp - 11/30/2016
5)      30 count Lot #0002073 Exp - 12/31/2016
6)      30 count Lot #0002108 Exp - 12/31/2016, 90 count Lot #0002078 Exp - 12/31/2016
7)      30 count Lot 211836
8)      Lot NVWG, Exp – 11/30/2016
RECALLING FIRM
Daiichi Sankyo Pharma Development, Edison, NJ
REASON FOR RECALL
Temperature Abuse; products were not stored at controlled room temperature during shipping
 
PRODUCT
Alprazolam Tablets, USP, 0.25mg, Rx only, NDC 0781-1060-10
CODE
Lot EJ9591, exp 5/2016
RECALLING FIRM
Sandoz Inc., Broomfield, CO
REASON FOR RECALL
Presence of Foreign Substance; stainless steel particles found in the API
 
 
  •  Pending Recalls for the July 23, 2014 Enforcement Report

 

PRODUCT:
SODIUM BICARBONATE 4.2% Neutralizing Additive Solution (2.5 mEq / 5 mL), 5 mL Single Dose Vial. NDC: 63323-026-05.
CODE:
Lot #: 6003426, Expiry: 07/2014; Lot #: 6003575, Expiry: 08/2014; Lot #: 6003590, Expiry: 08/2014.
RECALLING FIRM:
Fresenius Kabi USA, LLC. Grand Island, NY. 
REASON FOR RECALL:
Presence of Particulate Matter; Particulates consistent with glass delamination found in vials.
 
PRODUCT:
All Drug Prescriptions within expiry that were processed on or after 4/04/2014
CODE:
All lots within expiry
RECALLING FIRM:
Franck's Lab Inc dba Trinity Care Solutions, Ocala FL
REASON FOR RECALL:
Lack of Assurance of Sterility
 
PRODUCT:
1)Ibuprofen Tablets, USP, 600 mg, 100 UD blister cards, NDC 68084-703-01
2) Oxcarbazepine Tablets, USP 300mg, 100 UD blister cards, NDC 62584-143-11
CODE:
1) 142588
2) 142544
RECALLING FIRM:
American Health Packaging, Columbus, OH
REASON FOR RECALL:
Label Mix Up
 
PRODUCT:
Aspirin Enteric Coated Tablets 325 mg, UD 750, NDC 63739-523-01
CODE:
Lot 93943, exp 09/14
RECALLING FIRM:
McKesson Packaging Services, Concord, NC
REASON FOR RECALL:
Failed Dissolution Specification
 
 
  •  Pending Recalls for the July 16, 2014 Enforcement Report

 

PRODUCT: Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Fliptop Vial. NDC: 0409-9094-61.
CODE:
Lot #: 39474DK, Expiry: 03/01/2016.
RECALLING FIRM:
Hospira, Rocky Mount, NC
REASON FOR RECALL:
Lack of Assurance of Sterility: Vial crimps are loose or missing.
 
PRODUCT
  1. 0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX container bags (NDC 0338-0049-41, Product Code 2B1306) and b) 100 mL VIAFLEX container bags (NDC 0338-0049-18, Product Code 2B1302)
  2. 0.9% Sodium Chloride Injection USP, 50 mL MINI-BAG Plus Container bag, NDC 0338-0553-11, Product Code 2B0042
  3. Potassium Chloride Injection, 20 mEq per 50 mL (400 mEq/L) Sterile Single Dose Container bag, NDC 0338-0703-41, Product Code 2B0822
CODE
  1. Lot #: a) P309187, Exp 10/14; b) P298190, Exp 08/14
  2. Lot #: P308650, Exp 10/14
  3. Lot #: P309476, Exp 10/14
RECALLING FIRM
Baxter Healthcare Corp., Deerfield, IL
REASON FOR RECALL
Presence of Particulate Matter: These intravenous (IV) solutions are being recalled due to confirmed complaints of visible particulate matter.
 
 
PRODUCT
  1. POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg, Codeine Phosphate 10 mg, Phenylephrine HCl 7.5 mg, 16 fl oz. (473 mL) Bottle, NDC: 50991-713-16.
  2. LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5 mg, 16 fl oz. (473 mL), NDC: 50991-515-16.
CODE
  1. Lot #: 04413, Expiry: 02/15
  2. Lot #: 03613, Expiry: 02/15
RECALLING FIRM
Poly Pharmaceuticals, Inc, Owens Cross Roads, AL
REASON FOR RECALL
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
 
 
  • Pending Recalls for the July 2, 2014 Enforcement Report

 

PRODUCT
  1. Mometasone 0.6 mg /60 mL Irrigation solution, 4000 mL bottle
  2. Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle
  3. HCG (Human Chorionic Gonadotropin) 125 units/ 0.1 mL drop, 5 mL bottle
  4. HCG 125U/Tab Tablet Tritu, 50 tablets per bottle
  5. HCG (Human Chorionic Gonadotropin) 200 units/ 0.1 mL drops, packaged in 5 mL and 10 mL bottles
  6. HCG (Human Chorionic Gonadotropin) + Methylcobalamin (Methyl B12), 1500 units + 1000 mcg/mL drop, 8 mL bottle
CODE
  1. Lot # / Beyond Use Date: 04282014@11 / BUD 05/28/14; 04212014@4 / BUD 05/21/2014
  2. Lot # / Beyond Use Date: 05012014@36 / 05/15/14
  3. Lot # / Beyond Use Date: 05192014@15 / BUD 07/18/14; 04142014@39 / BUD 6-13-14; 04182014@4 / BUD 6-17-14; 04162014@12 / BUD 06/15/14; 05092014@34 / BUD 07/08/14; 04162014@35 / BUD 06/15/14; 05232014@33 / BUD 07/22/14; 05022014@36 / BUD 7/1/14; 04292014@13 / BUD 06/28/14; 04282014@43 / BUD 06/27/14; 05212014@5 / BUD 07/20/14; 04292014@13 / BUD 06/28/14; 05062014@42 / BUD 07/05/14; 05022014@36 / BUD 07/01/14; 05062014@45 / BUD 07/05/14; 05082014@2 / BUD 07/07/14, 05152014@36 / BUD 7/14/14; 05212014@5 / BUD 07/20/14; 05082014@2 / BUD 07/07/14; 05132014@37 / BUD 07/12/14; 05082014@2 / BUD 07/07/14; 05132014@38 / BUD 07/12/14; 04242014@14 / BUD 6-23-14; 04162014@12 / BUD 6-15-14; 04212014@27 / BUD 6-20-14; 04292014@13 / BUD 6-28-14; 05092014@34 / BUD 7-8-14; 05212014@5 / BUD 7-20-15; 05272014@58 / BUD 7-26-14; 05222014@27 / BUD 07/21/14
  4. Lot # / Beyond Use Date: 05022014@5 / BUD 07/01/14; 04032014@7 / BUD 06/02/14; 04092014@16 / BUD06/08/14; 04142014@51 / BUD 06-13-14; 04152014@48 / BUD 06/14/14; 04172014@42 / BUD 06-06-14; 04182014@45 / BUD 6-17-14; 05162014@41 / BUD 07/15/14; 04172014@44 / BUD 06/16/14; 04212014@37 / BUD 6/20/14; 04222014@10 / BUD 06/21/14; 04232014@30 / BUD 06/22/14; 05072014@37 / BUD 07-06-14; 04292014@31 / BUD 06/28/14; 04302014@9 / BUD 06/29/14; 04252014@43 / BUD 06/24/14; 04222014@28 / BUD 6 -21-14
  5. Lot # / Beyond Use Date: 04232014@49 / BUD 06-22-14; 04232014@2 / BUD 06/22/14; 04252014@27 / BUD 06/24/14; 04162014@33 / BUD06/15/14; 05132014@2 / BUD 07/12/14; 05092014@39 BUD 7-8-14
  6. Lot # / Beyond Use Date: 04302014@21 / BUD 06/29/14
RECALLING FIRM
Brookfield Prescription Center Inc. dba MD Custom Rx, Brookfield, WI
REASON FOR RECALL
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
 
PRODUCT
Ascorbic Acid 500 mg/mL Sterile Injection 50 mL Multi-dose Vial
CODE
Lot:06062014@8, Do Not Use Beyond: 12/03/2014
RECALLING FIRM
Pharmacy Creations, Randolph, NJ
REASON FOR RECALL
Non-Sterility: samples sent to an independent lab for sterility testing revealed the potential for mold growth.
 
  • Pending Recalls for the June 11, 2014 Enforcement Report

 

PRODUCT
Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6.
CODE
Lots: 10002-1, 00006-1, Exp 08/14;  10003A, Exp 11/14; 10004A, Exp 02/15; 10005A, 10005AR, 10007A, 10006A, Exp 07/15; and 10008A, Exp 08/15
RECALLING FIRM
Alexion Pharmaceuticals, Inc., Cheshire, CT
REASON FOR RECALL
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
 
  • Pending recalls for the June 4, 2014 Enforcement Report

 

PRODUCT
Calcitriol Oral Solution 1 mcg/mL, 15 mL bottle, Rx only, NDC 0054-3120-41
CODE
Lot # 360122A, EXP Date: MAY 2015
RECALLING FIRM
Roxane Laboratories, Inc., Columbus, Ohio
REASON FOR RECALL
Impurity/Degradation Failure; 9 month stability timepoint
 
  • Pending recalls for the May 21, 2014 Enforcement Report

PRODUCT

Oasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl. oz. Bottle, OTC Only. Distributed by: OASIS, OASIS Medical, Inc., Glendora, CA 91741. UPC: 8 54819 00002 3.
CODE
Lot #: OTM-07, Expiry: 12/2015.
RECALLING FIRM
Oasis Medical Inc
Glendora, CA
REASON FOR RECALL
Labeling: Missing Label; Label on the immediate bottle is missing.
 
  • Pending recalls for the May 7, 2014 Enforcement Report

 

PRODUCT
Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USP, NDC 0409-1559-10.
CODE
Lot #: 34-440-DD, Exp 10/15
RECALLING FIRM
Hospira Inc., Lake Forest, IL
REASON FOR RECALL
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
 
PRODUCT
PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Konsyl Pharmaceuticals, Inc., Easton, MD 21601. NDC: 0224-1847-10.
CODE
Lot #: A44701 (expiry: 07/16) , A44701C (expiry: 07/16), J34701C-1 (expiry: 07/16)
RECALLING FIRM
Konsyl Pharmaceuticals, Inc. Easton, MD 21601
REASON FOR RECALL
Labeling: Label Error on Declared Strength; Active ingredient strength is incorrect.
 
PRODUCT
Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, NDC 0008-1211-30 
CODE
H74477, H74478, Exp. 03/16, H74479, H79766 Exp. 05/16
RECALLING FIRM
Pfizer Us Pharmaceutical Group, New York, NY 10017
REASON FOR RECALL
Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.
 
  • Pending recalls for the April 30, 2014 Enforcement Report

 

PRODUCT
ParaGard T 380A - Intrauterine Copper Contraceptive, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY, packaged in a single unit 3 X 11 7/8 Mylar Tyvex pouch of 100 IUDs (1-pack), and 3 X 11 7/8 Mylar Tyvex pouch inside a carton of 5 units(200 IUDs).
CODE
lot 508004, exp. 4/2015, NDC 51285-204-01; and lot 508004, exp. 4/2015, NDC 51285-204-02
RECALLING FIRM
TEVA Pharmaceuticals, USA Horsham, PA
REASON FOR RECALL
Lack of Assurance of Sterility
 
PRODUCT
Pantoprazole Sodium, Delayed release Tablets 40 mg, Rx only, NDC 0904-6235-61
Lorazepam USP Tablets, 1 mg, Rx only, NDC 0904-5981-61
CODE
M-01006, exp 09/2015
RECALLING FIRM
Legacy Pharmaceuticals Packaging, Eath City MO
REASON FOR RECALL
Label Mixup; some cartons labeled to contain Pantoprazole Sodium tablets actually contain Lorazepam tablets and vice versa
 
PRODUCT
Losartan Potassium Tablets,
CODE
Lot Number GS003057. Exp Date 03/2016.
RECALLING FIRM
Golden State Medical Supply Inc., Camarillo, CA
REASON FOR RECALL
Presence of Foreign Substance
 
  • Pending recalls for the April 23, 2014 Enforcement Report

 

PRODUCT
Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, 6, 8, and 10 oz Bottles, OTC Only. Labeled A) Aaron Health, 10 FL OZ, Manufactured by Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; B) Aaron Health, 8 FL OZ, Manufactured by: PL Developments, 11865 S. Alameda St, Lynwood, CA 90262, UPC: 7 15256 71428 0; C) Aaron Brands, 6 FL OZ, Manufactured by: Aaron Industries, Inc., P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73506 3; D) Aaron Health, 4 FL OZ, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73504 9; E) Best Choice, 6 FL OZ, Proudly Distributed By: Valu Merchandisers, CO., Kansas City, MO 64111, UPC: 0 70038 61984 0 F) Best Choice, 10 FL OZ, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC: 0 70038 61985; G) CareOne, 10 FL OZ, Distributed By American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086, UPC: 3 41520 31853 5; H) CareOne, 12 FL OZ, Distributed By: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086, UPC: 3 41520 31832 0; I) drug mart, 10 FL OZ, Distributed By: Discount Drug Mart-Food Fair, Medina, Ohio 44256, NDC: 93351-0142-1; J) DR, 6 FL OZ, Distributed by DUANEreade, 440 Ninth Avenue, NY, NY 10001, UPC: 6 39194 04479; K) DR, 10 FL OZ, Distributed by DUANEreade, 440 Ninth Avenue, NY, NY 10001, UPC: 6 39194 04480 6; L) equate, 10 FL OZ, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-142-01; M) equate: 12 FL OZ, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-142-02; N) exchange select, 10 FL OZ, Manufactured For: Your Military Exchanges, By Aaron Industries Inc., P.O. Box 801, Lynwood CA 90262, UPC: 6 14299 40234 8; O) Family wellness, 10 FL OZ, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105 USA, UPC: 0 32251 00504 6; P) Fred's, 10 FL OZ, Distributed By: Fred's, Inc., 4300 New Getwell Rd, Memphis, TN 38118, UPC: 0 84579 11020 9; Q) Laura Lynn, 6 FL OZ, Distributed by: Ingles Markets, Asheville, NC 28816, UPC: 0 86854 04767 5; R) LiveBetter, 10 FL OZ, Distributed By Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, NDC: 49580-3416-1; S) LiveBetter, 6 FL OZ, Distributed By Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, NDC: 41310-0142-6; T) Marc's, 10 FL OZ, Distributed by: Marc Glassman Inc. Manufactured by: Aaron Industries, Inc., P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; U) 666 COLD Preparation, 4 FL OZ, Distributed by: Monticello Drug Company, Jacksonville, FL 32204, UPC: 3 11868 00224 3; V) 666 COLD Preparation, 8 FL OZ, Distributed by: Monticello Drug Company, Jacksonville, FL 32204, UPC: 3 11868 00228 1; W) Our Family, 12 FL OZ, Distributed By: Nash Finch Company, NFC Brands, 7600 France Ave S, MPLS, MN 55435, UPC: 0 70253 97109 9; X) Our Family, 10 FL OZ, Distributed By: Nash Finch Company, NFC Brands, 7600 France Ave S, MPLS, MN 55435, UPC: 0 70253 96745 0; Y) Premier Value, 6 FL OZ, Distributed By: Chain Drug Consortium, LLC., 2300 NW Corporate Blvd., Suite 115, Boca Rataon, FL 33431, NDC: 68016-0023-79; Z) Premier Value, 8 FL OZ, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suit 101, Boca Raton, FL 33431, NDC: 68013-142-08; AA) Premier Value, 10 FL OZ, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suit 101, Boca Raton, FL 33431, NDC: 68013-142-01; BB) Publix, 10 FL OZ, Distributed By: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, 0 41415 27073 2; CC) Quality Choice, 8 FL OZ, Distributed by C.D.M.A. Inc., 43157 W. Nine Mile, Novi, MI 48376, NDC: 63868-245-08; DD) Quality Choice, 10 FL OZ, Distributed by Quality Choice, Novi, MI 48376, NDC: 63868-0245-10; EE) Quality Choice, 12 FL OZ, Distributed by C.D.M.A. Inc., 43157 W. Nine Mile, Novli, MI 48376, NDC: 63868-245-12; FF) Rite Aid, 6 FL OZ, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 33572 0; GG) Rite Aid, 8 FL OZ, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 88572 0; HH) Rite Aid, 10 FL OZ, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 55643 9; II) Rite Aid, 12 FL OZ, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 88643 7; JJ) Safeway, 12 FL OZ, Distributed By Safeway Inc., P.O. Box 99, Pleasnton, CA 94566, NDC: 21130-142-02; KK) select brand, 6 FL OZ, Distributed by: Select Brand Distributors, Pine Bluff, AR 71603, NDC: 15127-910-06; LL) select brand, 10 FL OZ, Distributed by: Select Brand Distributors, Pine Bluff, AR 71603, NDC: 15127-808-10; MM) ShopRite, 10 FL OZ, Distributed By: Wakefern Food Corporation, 5000 Riverside Drive, Keasbey, NJ 08832, UPC: 0 41190 22274 2; NN) Western Family, 12 FL OZ, Proudly Distributed by: Western Family Foods, Inc., P.O. Box 4057, Portland, OR 97208, UPC: 0 15400 12991 6.
CODE
Lot # (expiry): Aaron Health A-D) 72493 (5/14), 75241 (7/14), 77879 (8/14), 78795 (9/14), 81058 (11/14), 81118 (10/14), 81578 (10/14), 82076 (10/14), 82023 (11/14), 140756 (1/15), 141655 (11/14), 141882 (3/15), 142086 (2/15), 144257 (1/15), 147361 (3/15), 148288 (6/15), 149143 (7/15), 149512 (7/15), 149741 (8/15), 150307 (9/15), 152290 (3/15), 152666 (11/15), 152752 (8/15), 154931 (10/15), 155111 (1/16). BestChoice E-F) 76825 (7/14), 78792 (7/14), 78798 (9/14), 79357 (6/14), 79732 (9/14), 79733 (9/14), 81066 (11/14), 81695 (10/14), 83452 (12/14), 83682 (1/15), 83843 (1/15), 140395 (1/15), 142314 (3/15), 147440 (1/15), 148095 (6/15), 149404 (8/15), 149445 (8/15), 152521 (8/15), 152521 (8/15), 152866 (8/15), 153069 (8/15), 153900 (12/15), 154463 (12/15), 154919 (12/14), 154957 (1/14). CareOne G-H) 73250 (5/14), 77891 (8/14), 78801 (9/14), 81580 (10/14), 7325001 (5/14), 7397801 (6/14), 7788001 (8/14), 8158001 (10/14), 8321501 (1/15), 14048301 (1/15), 14126901 (2/15). Drug Mart I) 77886 (8/14), 83479 (1/15), 141268 (2/15), 143648 (3/15), 144828 (3/15), 148472 (6/15), 148483 (6/15), 151620 (10/15), 152667 (11/15). Duanereade J-K) 73377 (5/14), 73977 (5/14), 74888 (5/14), 76136 (7/14), 77068 (7/14), 77875 (7/14), 80308 (7/14), 81067 (11/14), 81069 (10/14). Equate L-M) 73736 (6/14), 74386 (6/14), 75111 (7/14), 75824 (7/14), 76826 (8/14), 78210 (9/14), 78417 (9/14), 78457 (9/14), 78858 (9/14), 78859 (9/14), 78860 (9/14), 79182 (10/14), 79564 (10/14), 80310 (10/14), 80311 (10/14), 80312 (10/14), 81071 (10/14), 81184 (11/14), 81331 (11/14), 81931 (12/14), 82010 (12/14), 82533 (12/14), 82913 (12/14), 83797 (12/14), 83798 (12/14), 83799 (12/14), 83943 (1/15), 84098 (1/15), 140937 (2/15), 141126 (2/15), 141127 (2/15), 141204 (2/15), 141831 (2/15), 143619 (2/15), 145776 (2/15), 146377 (2/15), 146766 (2/15), 147479 (2/14), 148254 (2/15), 148733 (8/15), 148876 (2/15), 148877 (2/15), 149282 (8/15), 149497 (8/15), 150586 (8/15), 150922 (8/15), 150923 (9/15), 151132 (9/15), 151261 (10/15), 152254 (10/15), 152447 (11/15), 152758 (11/15), 152759 (11/15), 153095 (11/15), 153096 (11/15), 153714 (11/15), 154488 (122/15), 154980 (1/16), 155574 (1/16). Exchange Select N) 71901 (5/14), 72662 (5/14), 73737 (6/14), 75112 (7/14), 76827 (8/14), 77881 (8/14), 78490 (8/14), 78996 (9/14), 80010 (9/14), 80112 (9/14), 81579 (10/14), 82411 (10/14), 83477 (1/15), 84095 (1/15), 84096 (1/15), 140484 (1/15), 140767 (1/15), 141270 (2/15), 141758 (1/15), 142315 (3/15), 142867 (3/15), 143367 (3/15), 143755 (3/15), 144067 (3/15), 144552 (3/15), 144791 (3/15), 145197 (3/15), 146104 (3/15), 146340 (6/15), 147439 (6/15), 147654 (3/15), 148584 (6/15), 149826 (8/15), 150417 (9/15), 151242 (10/15), 152072 (10/15), 152075 (10/15), 152428 (11/15), 152929 (11/15), 156099 (2/16). Family Wellness O) 72620 (5/14), 72826 (5/14), 73026 (5/14), 74080 (6/14), 74764 (6/14), 75115 (7/14), 75409 (7/14), 76988 (8/14), 77492 (8/14), 77492 (8/14), 77808 (8/14), 77809 (8/14), 77810 (8/14), 78165 (9/14), 78550 (9/14), 78823 (9/14), 78824 (9/14), 78918 (9/14), 79491 (9/14), 79734 (9/14), 79735 (10/14), 79736 (10/14), 80086 (10/14), 80753 (10/14), 80754 (10/14), 81330 (10/14), 83218 (1/15), 83480 (1/15), 83684 (1/15), 133190 (1/15), 140366 (1/15), 141557 (2/15), 143346 (3/15), 143788 (3/15), 143844 (3/15), 145267 (3/15), 146107 (6/15), 146960 (6/15), 147438 (6/15), 148175 (6/15), 148289 (6/15), 149094 (6/15), 149095 (7/15), 149281 (7/15), 149827 (8/15), 150310 (9/15), 151063 (10/15), 151064 (10/15), 151369 (10/15), 151370 (10/15), 151833 (10/15), 151834 (10/15), 151902 (10/15), 151903 (10/15), 152867 (11/15), 153245 (11/15), 153839 (12/15), 154022 (12/15), 154494 (12/15). P) Fred's: 74155 (6/14), 75343 (6/14), 79119 (9/14), 81070 (10/14), 81782 (10/14), 83844 (1/15), 141265 (1/15), 142813 (3/15), 144463 (3/15), 144792 (3/15), 145061 (3/15), 145473 (3/15), 150309 (9/15), 152292 (10/15), 152293 (10/15), 153836 (11/15), 156097 (1/14). Laura Lynn Q) 75982 (5/14), 77876 (7/14), 140396 (1/15), 151059 (8/15), 152787 (8/15), 153070 (8/15), 153205 (8/15), 153901 (12/15), 155627 (12/15), 155791 (12/14). LiveBetter R-S) 71902 (5/14), 72825 (5/14), 73892 (5/14), 73979 (6/14). Marc's T) 73981 (6/14), 140160 (1/15), 144514 (3/15), 146639 (3/15), 146641 (6/15). 666 COLD U-V) 78951 (8/14), 81716 (10/14), 81868 (10/14), 141028 (8/14), 141032 (12/14), 141756 (12/14), 141757 (2/15), 145551 (12/14), 147710 (12/14), 149093 (7/15), 151328 (7/15), 151619 (10/15). Our Family W-X) 78802 (9/14), 80662 (10/14), 82458 (12/14), 82569 (12/14), 84097 (1/15), 142342 (2/15), 145770 (2/15), 146105 (2/15), 150010 (8/15), 151372 (10/15), 152523 (11/15), 7205001 (5/14), 7788201 (8/14). Premier Value Y-AA) 72618 (5/14), 73893 (5/14), 73980 (6/14), 74763 (5/14), 75903 (5/14), 75904 (6/14), 75905 (6/14), 75906 (6/14), 75907 (6/14), 76255 (7/14), 77877 (7/14), 77883 (8/14), 78793 (7/14), 79670 (7/14), 81068 (11/14), 81119 (10/14), 81261 (9/14), 81775 (11/14), 82075 (11/14), 82125 (10/14), 82716 (11/14), 83216 (1/15), 83478 (1/15), 140485 (1/15), 142147 (3/15), 142496 (1/15), 143345 (1/15), 145207 (1/15), 145936 (1/15), 145937 (3/15), 147253 (3/15), 147262 (2/15), 147365 (2/15), 153837 (11/15), 153903 (10/15), 155861 (12/15). Publix BB) 71959 (4/15), 72475 (5/14), 72619 (5/14), 74086 (6/14), 75184 (7/14), 77889 (8/14), 77890 (9/14), 79492 (6/14), 79493 (7/14), 79494 (7/14), 79495 (9/14), 79496 (9/14), 141348 (2/15), 142268 (3/15), 142665 (1/15), 142666 (2/15), 142667 (3/15), 142668 (3/15), 142751 (3/15), 147094 (6/15), 147432 (9/14), 147436 (3/15), 147437 (3/15), 147893 (6/15), 149405 (8/15), 149828 (8/15), 151371 (10/15), 152668 (11/15), 153828 (11/15), 154232 (12/15), 154783 (12/15), 155383 (1/16), 155470 (1/14), 155471 (1/14), 156098 (1/14), 7261901 (5/14). Quality Choice CC-EE) 148333 (8/15), 148335 (2/15), 148555 (2/15), 149817 (8/15), 149819 (8/15), 149967 (9/15), 150011 (8/15), 150071 (9/15), 150312 (8/15), 150786 (9/15), 150860 (9/15), 152868 (11/15), 154234 (12/15), 155476 (1/14), 7190301 (5/14), 7239801 (5/14), 7444801 (6/14), 7458901 (6/14), 7788701 (8/14), 7879701 (9/14), 8030901 (10/14), 8075501 (10/14), 8186901 (10/14), 8231001 (10/14), 8321701 (12/14), 8368301 (12/14), 8368301 (1/15), 8384501 (1/15), 14112301 (1/15), 14640501 (6/15), 14761401 (4/15), 14848401 (6/15), 15106201 (10/15). RiteAid FF-II) 72517 (5/14), 72728 (5/14), 73745 (6/14), 74333 (6/14), 74973 (5/14), 75298 (5/15), 76137 (5/14), 76712 (8/14), 76828 (8/14), 77316 (8/14), 77504 (8/14), 80201 (8/14), 80202 (10/14), 80756 (10/14), 80848 (10/14), 81426 (10/14), 81427 (11/14), 81714 (10/14), 81878 (11/14), 81932 (12/14), 82009 (10/14), 143601 (3/15), 143843 (3/15), 144668 (2/15), 144953 (3/15), 144954 (2/15), 145169 (3/15), 145266 (3/15), 145660 (2/15), 146677 (3/15), 146678 (2/15), 146959 (3/15), 147186 (2/15), 147206 (2/15), 147774 (2/15), 147776 (2/15), 148098 (2/15), 148099 (2/15), 148174 (8/15), 148334 (8/15), 149966 (9/15), 150743 (9/15), 151997 (10/15), 152094 (9/15), 152095 (10/15), 152427 (11/15), 153588 (11/15), 154233 (12/15), Safeway JJ) 76406 (8/14), 76407 (8/14), 7732801 (8/14), 7801301 (8/14), 7801401 (8/15), 7801501 (8/14), 7853901 (9/14), 7973701 (10/14), 7973801 (10/14), 8008701 (10/14), 8050601 (10/14), 8088801 (10/14), 8116101 (10/14), 8133201 (10/14), 8200801 (12/14), 8212601 (10/14), 8223401 (12/14), 8231101 (12/14), 8257001 (12/14), 8282701 (12/14), 8394401 (1/15), 14016101 (1/15), 14083101 (2/15), 14127101 (2/15), 14141701 (2/15), 14155801 (2/15), 14336801 (2/15), 14584601 (2/15), 14584701 (2/15), 14935801 (2/15), 14935901 (8/15), 14961101 (8/15), 14968401 (8/15), 14985301 (8/15), 15031101 (8/15), 15078701 (9/15), 15132901 (10/15), 15194101 (10/15), 15218301 (10/15), 15408201 (12/15), 15438501 (12/15), 15468101 (12/15), 15495801 (1/16), 15547301 (1/14), Select Brand KK-LL) 74676 (5/14), 75144 (7/14), 76711 (7/14), 77878 (7/14), 77884 (8/14), 78549 (8/14), 78800 (9/14), 79207 (7/14), 79446 (7/14), 80471 (9/14), 82593 (10/14), 83125 (12/14), 83453 (11/14), 140159 (1/15), 140397 (1/15), 140757 (1/15), 140766 (1/15), 144790 (1/15), 147362 (1/15), 151061 (10/15), 152522 (8/15), 152644 (8/15), 152928 (12/15), 153902 (12/15), ShopRite MM) 77885 (8/14), 79120 (9/14), 79447 (6/14), 81940 (10/14), 82412 (10/14), Western Family NN) 145421 (2/15), 146805 (2/15), 155954 (1/16).
RECALLING FIRM P & L Developments, LLC, 11865 S. Alameda St, Lynwood, CA 90262
REASON FOR RECALL Subpotent Drug; Phenylephrine is Subpotent
 
 
PRODUCT
Children's Triacting Night Time Cold & Cough with PE Product Label: Pedia Care, UPC 8 14832 01354 7, 4oz.; Good Neighbor Pharmacy, UPC 0 87701 40599 0, 4oz.; Family Wellness, UPC 032251 03394 0, 4oz.; Aaron Health, UPC 715256 72204 9, 4oz.; Safeway, UPC 3 21130 78207 0, 4oz.; Walgreens, UPC 3 11917 12056 0, 4oz.; Quality Choice, UPC 6 35515 96577 5, 4oz.
CODE 73142, 73242, 73243,73671,73244, 74206, 74830, 79325, 79349, 79355, 79747, 80456, 73718, 73824, 73825, 73898, 74141, 74207, 74303, 74460, 74459, 74194, 74898, 74900,75103, 74899,75306, 75339, 75179, 75455, 75671, 76022, 80017, 80457, 80781,81263, 81884, 81953, 78531, 78803, 78804, 78805, 81954, 79089, 79050, 79183, 79573, 79265, 79267, 79264, 79266, 79324, 79671, 79443, 80599, 81121, 81960, 82006, 82047, 81955, 82178, 82312, 82500, 82573, 82826, 83745, 83746, 83726, 145826, 133195, 133192, 133193, 133194, 133196, 133197, 140252, 140385, 140292, 145828 140966, 141023, 141202, 141656, 141692, 141936, 141937, 142148, 142316, 142669, 143201, 143399, 143656, 145170, 145249, 145268, 144273, 145829, 146058, 146406, 146425, 146963, 150302, 145690, 14726901, 147613, 147961, 148105, 14812901, 148247,148809 ,14755501, 148341, 14829601, 148297, 150304, 148344, 14914401, 149149, 149317,149296, 149447, 149515, 149914, 149815, 150305, 150549, 150673,151650,152345,152870, 15074701, 150866, 151039, 151465, 151651, 151762, 151573, 151906, 152297, 152798, 153206, 153207,153514,154024,154090, 154091, 154303, 15434701, 154923, 15497301, 154922, 155380, 155479, 155631
RECALLING FIRM  P & L Developments, LLC, 11865 S. Alameda St, Lynwood, CA 90262
REASON FOR RECALL: Presence of Precipitated Diphenhydramine
 
PRODUCT
Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-0380-1.
CODE
Lot #: KD4855, Exp 06/14
RECALLING FIRM
Apotex Inc., Toronto, Canada
REASON FOR RECALL
Failed Impurities/Degradation Specifications: Out of Specification for an unidentified impurity at the 18 month stability time point.
 
PRODUCT
CUBICIN (daptomycin for injection) 500 mg in 10 mlL single use vials, NDC 67919-011-01
CODE
280453F, Exp 04/16
RECALLING FIRM
Cubist Pharmaceuticals, Inc., Lexington, MA
REASON FOR RECALL
Presence of Particulate Matter: identified as glass particles
 
PRODUCT
Oxandrolone Tablets, USP, 10 mg, 60-count bottles, NDC 0245-0272-06
CODE
2802.042A, Exp 10/2015
RECALLING FIRM
Upsher Smith Laboratories, Inc., Maple Grove Minnesota 55369
REASON FOR RECALL
Labeling: Missing Label
 
 
PRODUCT
a) Methyldopa Tablets USP, 500 mg, 100 count, NDC:0093-2932-01
b) Glyburide and Metformin Hydrochloride Tablets USP, 5mg/500mg, 500 count NDC: 0093-5712-05
c) Indomethacin Capsules USP, 25 mg 100 count, NDC 0093-4029-01
d) Indomethacin Capsules USP, 50 mg, 100 count, NDC 0093-4030-01, and 500 count, NDC 0093-4030-05
 
CODE
a) TE36053A, exp. 06/16
b) TE36018, exp. 06/15
c) TE32134, exp. 02/15
d) TE38139, exp. 08/16, TE39022, exp. 09/16
 
RECALLING FIRM
Teva Pharmaceuticals USA, Horsham PA 19044
 
REASON FOR RECALL
GMP Deviations
 
 
  • Pending recalls for the April 16, 2014 Enforcement Report
PRODUCT
  1. Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 41616 75883 2); and b) 90-count bottles (NDC 41616-758-81, UPC 3 41616 75881 8)
  2. Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a)30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5); and b) 90-count bottles (NDC 41616-760-81, UPC 3 41616 76081 1)
CODE
  1. a) JKL3354A, Exp 04/14; JKL5444A, Exp 08/14; JKL5457B, JKL5445A, Exp 09/14; JKL5840A, Exp 10/14; JKL6588A, Exp 11/14; b) JKL3354B, Exp 04/14; JKL5444B, Exp 08/14; JKL5457C, JKL5445B, Exp 09/14; JKL5840B, Exp 10/14
  2. a) JKL4344A, Exp 07/14; JKL5460A, Exp 10/14; JKL5458A, Exp 11/14; b) JKL4344B, Exp 07/14; JKL5460B, Exp 10/14; JKL5458B, Exp 11/14
RECALLING FIRM
Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI  48202
REASON FOR RECALL
Failed Dissolution Specifications: Stability results found the product may not meet the drug release dissolution specification at the 8 hour timepoint
 
 
PRODUCT
Children’s Cetirizine Hydrochloride Chewable Tablets, 5 mg (NDC 47335-343-83) and 10 mg (NDC 47335-344-83) distributed by Caraco Pharmaceutical Laboratories. Detroit, MI and 10 mg (NDC 68016-353-30) distributed by Premier Value, Chain Drug Consortium, Boca Raton, FL
CODE
5 mg:  JKM2067A, JKM2068A, JKM2069A, JKM6399A
10 mg: JKM2070A, JKM2071A, JKM2072A, JKM2072B, JKM6400A
RECALLING FIRM
Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI 48202
REASON FOR RECALL
Failed Impurity/Degradation specifications
 
 
PRODUCT
  1. Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 41616 75883 2); and b) 90-count bottles (NDC 41616-758-81, UPC 3 41616 75881 8)
  2. Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a)30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5); and b) 90-count bottles (NDC 41616-760-81, UPC 3 41616 76081 1)
CODE
  1. a) JKL3354A, Exp 04/14; JKL5444A, Exp 08/14; JKL5457B, JKL5445A, Exp 09/14; JKL5840A, Exp 10/14; JKL6588A, Exp 11/14; b) JKL3354B, Exp 04/14; JKL5444B, Exp 08/14; JKL5457C, JKL5445B, Exp 09/14; JKL5840B, Exp 10/14
  2. a) JKL4344A, Exp 07/14; JKL5460A, Exp 10/14; JKL5458A, Exp 11/14; b) JKL4344B, Exp 07/14; JKL5460B, Exp 10/14; JKL5458B, Exp 11/14
RECALLING FIRM
Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI  48202
REASON FOR RECALL
Failed Dissolution Specifications: Stability results found the product may not meet the drug release dissolution specification at the 8 hour timepoint
 
 
  • Pending recalls for the April 9, 2014 Enforcement Report
PRODUCT
1)      Pleo Not PORTABLE SIPS 7X, 10 and 50 x 1 mL vials, NDC: 49807-2310-X;
2)      Pleo Not PORTABLE SIPS 6X, 10 and 50 x 1 mL vials, NDC: 49807-2308-X;
3)      Pleo Not PORTABLE SIPS 5X, 10 and 50 x 1mL vials, NDC: 49807-2306-X,
4)      Pleo Not DROPS 5X – 10 mL bottles, NDC: 49807-2301-1;
5)      Pleo Not TABLETS 5X, 20 tablet cartons, NDC: 49807-2302-1;
6)      Pleo Not CAPSULES 4X, 20 tablet carton, NDC: 49807-2303-1;
7)      Pleo Not SUPPOSITORIES 3X, 10 suppository cartons, NDC: 49807-2304-1;
8)      Pleo Not OINTMENT 3X, 30 g tube, 49807-2305-1;
9)      Pleo Fort TABLETS 5X, 20 tablet carton, NDC: 49807-1102-1;
10) Pleo Fort DROPS 5X, 10 mL bottle, NDC: 49807-1101-1;
11) Pleo Fort PORTABLE SIPS 5X, 50, 10 x 1 mL vials, NDC: 49807-1105-X;
12) Pleo Fort CAPSULES 4X, 20 capsule carton, NDC: 49807-1103-1;
13) Pleo Fort SUPPOSITORIES 3X, 10 suppository carton, NDC: 49807-1106-1;
14) Pleo Ex PORTABLE SIPS 5X, 50, 10 x 1 mL vials, NDC: 49807-1005-X;
15) Pleo Ex DROPS 5X, 10 mL bottles, NDC: 49807-1003-1;
16) Pleo Ex SUPPOSITORIES 3X, 10 suppository carton, NDC: 49807-1001-1;
17) Pleo Stolo DROPS 6X, 10 mL bootle, NDC: 49807-0011-1;
18) Pleo Quent PORTABLE SIPS 5X, 50, 10 x 1 mL vials, NDC: 49807-2905-X;
19) Pleo Quent DROPS 5X, 10 mL bottle, NDC: 49807-2901-1;
20) Pleo Quent CAPSULES 4X, 20 capsule carton, NDC: 49807-2902-1;
21) Pleo Quent SUPPOSITORIES 3X, 10 suppository cartons, NDC: 49807-2904-1;
22) Pleo Nota-Quent DROPS 5X, 10 mL bottles, NDC: 49807-0031-1.
 
CODE
1)      (10 x 1 mL) Portable Sips: Batch # 20010, EXP: December 2014. (50 x 1ml) Portable Sips: Batch # 20010, EXP: December 2014
2)       (10 x 1mL) Batch # 25050, EXP: April 2015. (50 x 1mL): Batch # 25050, EXP: April 2015.
3)      (10 x 1mL): Batch # 07099, EXP: August 2014; Batch # 15090; EXP: August 2015; Batch # 06120, EXP: November 2015; Batch #19023; EXP: January 2018. (50 x 1ml) Portable Sips: Batch # 07099, EXP: August 2014; Batch # 15090; EXP: August 2015; Batch # 1110, EXP: October 2015; Batch #6120; EXP: November 2015;Batch # 19023; EXP January 2018
4)      Batch # 21049, EXP: March 2014; Batch # 13059; EXP: April 2014; Batch # 09080, EXP: July 2015; Batch #15100; EXP: September 2015; Batch # 24092; EXP: August 2017
5)      Batch # 15070, EXP: June 2015; Batch # 24072, EXP: June 2017
6)      Batch # 14010, EXP: December 2014; Batch # 11080, EXP: August 2015; Batch # 12092, EXP: July 2017
7)      Batch # 1080, EXP: July 2015; Batch # 1102, EXP: September 2017
8)      Batch # 03051, EXP: April 2014; Batch # 13072, EXP: June 2015; Batch #21033, EXP: April 2016
9)      Batch # 27100; EXP: September 2015; Batch # 29100; EXP: October 2015; Batch # 25013; EXP: January 2018
10) Batch # 23109; EXP: September 2014; Batch # 08030; EXP: February 2015; Batch # 12032; EXP: February 2017; Batch # 26043; EXP: March 2018
11) 10 x 1 ml Cartons: Batch # 15030; EXP: February 2015; Batch # 12122; EXP: November 2017. 50 x 1 ml: Batch # 15030; EXP: February 2015; Batch # 12122; EXP: November 2017
12) Batch # 24030; EXP: February 2015; Batch # 14062; EXP: May 2017
13) Batch # 3110; EXP: October 2015; Batch # 1112; EXP: October 2017
14) 10 x 1 mL: Batch # 09020; EXP: January 2015; Batch # 03052, EXP: April 2017. 50 x 1 mL: Batch # 09020; EXP: January 2015; Batch # 03052, EXP: April 2017
15) Batch # 07011; EXP: December 2015; Batch # 09043, EXP: March 2108
16) Batch # 2011; EXP: December 2015; Batch # 2081, EXP: July 2016; Batch # 3063, EXP: May 2018; Batch # 1013, EXP: February 2018
17) Batch # 08060; EXP: May 2015; Batch # 07119, EXP: August 2014; Batch # 03043, EXP: May 2018
18) 10 x 1 ml: Batch # 13090; EXP: August 2015. 50 x 1 ml: Batch #13090, EXP: August 2015
19) Batch # 15129; EXP: November 2014; Batch #12040, EXP: March 2015; Batch #01081, EXP: August 2016
20) Batch # 25030; EXP: April 2015; Batch # 27101, EXP: Sept 2016
21) Batch # 2089; EXP: June 2014; Batch #3031 , EXP: June 2016
22) Batch #04062 , EXP: May 2017; Batch #06062 , EXP: May 2017.
RECALLING FIRM
Terra Medica, Inc, Ferndale, WA
REASON FOR RECALL
Penicillin Cross Contamination
 
 
PRODUCT
VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial NDC 65757-300-01
CODE
412-3732AA; expiration date 07/16
RECALLING FIRM
Alkermes, Inc., Waltham, MA 02451
REASON FOR RECALL
Resuspension Problems; product is not dissolving completely after mixing causing clumping
 
  • Pending recalls for the April 2, 2014 Enforcement Report
PRODUCT
Duloxetine DR Capsules USP, a) 20 mg, 60-count bottle, b) 30 mg, 30 count bottle, c) 60 mg, 30 count bottle, Rx Only, manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, for: Teva Pharmaceuticals USA, Inc., Sellersville, PA.
NDC a) 0093-7542-06; b) 0093-7543-56; c) 0093-7544-56
CODE
a)      48D001, exp. 5/2015 ; and lot 48D002, exp. 9/2015; b) 49D001, exp. 4/2015; lot 49D002, exp. 6/2015; lot 49D003, exp. 7/2015; lot 49D004, exp. 9/2015; lot 49D005, exp. 9/2015; lot 49D006, exp. 9/2015 ; and lot 49D007, exp. 10/2015; c) 50D003, exp. 2/2015; lot 50D004, exp. 3/2015; lot 50D005, exp. 3/2015; lot 50D006, exp. 5/2015; lot 50D010, exp. 6/2015 ; lot 50D028, exp. 9/2015; lot 50D029, exp. 10/2015; lot 50D031, exp. 10/2015; lot 50D032, exp. 11/2015; and lot 50D033, exp. 11/2015.
RECALLING FIRM
Teva Pharmaceuticals USA, Horsham, PA
REASON FOR RECALL
Failed Tablet/Capsule Specifications: Reports of broken capsules
 
PRODUCT
Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, packaged in a) 30-count Unit of Use bottles (NDC 0008-0836-21) UPC 3 0008-0836-21 7; b) 90-count Unit of Use bottles (NDC 0008-0836-22) UPC 3 0008-0836-22 4; Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101.
CODE
V1300142, V130140, Exp 10/15
RECALLING FIRM
Pfizer Us Pharmaceutical Group, New York, NY
REASON FOR RECALL
Presence of Foreign Tablets/Capsules: a pharmacist reported that a bottle of Effexor XR 150 mg capsules was found to contain a single peach colored capsule imprinted with “TKN250” and identified as a Tikosyn (dofetilide) capsule.
 
PRODUCT
Venlafaxine HCL Extended-Release Capsules, 150 mg, 90-count Unit of Use bottles, Rx only, Distributed by: Greenstone LLC, Peapack, NJ  07977, NDC 59762-0182-2, UPC 3 59762-0182-2 9.
CODE
V130014, Exp 08/15
RECALLING FIRM
Greenstone Llc, Peapack, NJ
REASON FOR RECALL
Presence of Foreign Tablets/Capsules: a pharmacist reported that a single peach colored capsule imprinted with “TKN250” and identified as a Tikosyn (dofetilide) capsule was found in a lot packaged in the same packaging campaign as this venlafaxine HCl lot.
 
 
PRODUCT
a. Papaverine 60 mg, Phentolamine 4 mg, and Atropine 0.3 mg, 10 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
b. Phosphatidylcholine Solution 50 mg/ mL for Injection, 50 mL Vial, Rx Only, Not for Resale.  John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
c. Polidocanol 1% Solution, 50 mL Vial, Rx Only, Not for Resale.  John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
d. Polidocanol 3% Solution, 50 mL Vial, Rx Only, Not for Resale.  John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
CODE
a. Lot #: 1905, Expiry: 4/30/14
b. Lot #: 41652, Expiry: 8/2/14, Lot #: 41668, Expiry: 7/13/14
c. Lot #: 565:27, Expiry: 5/31/14
d. Lot #: 641:07, Expiry: 8/11/14
RECALLING FIRM
John Hollis Pharmacy, 110, 20th Avenue N, Nashville, TN 37203
REASON FOR RECALL
  1. Incorrect Expiration Date; Expiration date is 1 day earlier than listed on vial.
  2. Incorrect Expiration Date; Expiration date is 5- 16 months earlier than listed on vial
  3. Incorrect Expiration Date; Expiration date is 9 days earlier than listed on vial
  4. Presence of Particulate Matter
 
PRODUCT
QVAR® (beclomethasone dipropionate HFA), 40mcg INHALATION AEROSOL in Aluminum Cylinders, Rx only, NDC 59310-202-40 and NDC 59310-175-41
CODE
lot 120088, exp.3/2014, NDC 59310-202-40, 40 mcg,8.7g / 120 metered inhalations, lot 120491, exp. 10/2014, NDC 59310-175-41,40 mcg,7.3g / 100 metered inhalations
RECALLING FIRM
Teva Pharmaceuticals USA, Horsham, PA 19044-1220
REASON FOR RECALL
Failed Impurity/Degradation Specifications; 9 and 18 month stability time point
 
PRODUCT
Demerol (meperidine HCL) Injection USP, 25 mg/0.5 mL (50 mg/mL), Rx only, NDC 0409-1203-01
CODE
Lot: 221303A, 1OCT2014
RECALLING FIRM
Hospira Inc., Lake Forest, IL
REASON FOR RECALL
Labeling; Missing Label; ampules are missing the primary label
 
PRODUCT
SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg (as tiotropium) per capsule. For Respiratory Inhalation Packaged in: 30 count and 5 count blister cards
CODE
NDC 00597-0075-41 (30 count capsules); Lot# 3030128 Exp. SEP 2014 , 303125A, Exp. OCT 2014,  303253A, Exp. OCT 2014, 303895A, 304282A, Exp. NOV 2014, 304510A, Exp. DEC 2014;  NDC 00597-0075-75 (5 count capsules); Lot#  303012A, Exp. SEP 2014
RECALLING FIRM
Boehringer Ingelheim Roxane Inc., Columbus Ohio 43228-9579
REASON FOR RECALL
Defective Container: Potential for OOS for dose delivery
 
  •  Pending recalls for the March 26, 2014 Enforcement Report
PRODUCT
Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10 x 10), Rx Only, Manufactured by: Teva Pharmaceuticals USA, 1090 Horsham Rd, North Wales, PA 19454, NDC 63739-0512-10
CODE
91357
RECALLING FIRM
McKesson Packaging Services
7101 Weddington Rd NW
Concord, NC 28027
REASON FOR RECALL
Failed Dissolution Specification
 
PRODUCT
VPRIV (velaglucerase alfa for injection), lyophilized powder, 400 Units/vial, Rx only, NDC: 54092-701-04.
CODE
FEW13-001, FEW13-002, FED13-006, FED013-010, FED013-011
RECALLING FIRM
Shire Human Genetic Therapies, Inc., 300 Shire Way, Lexington, MA 02421.
REASON FOR RECALL
Presence of Particulate Matter Identified as Barium Sulfate and Stainless Steel
 
PRODUCT
Reumofan Plus Tablets, 30 Tablet Bottles, OTC, Remainder of Label in Spanish
CODE
99515
RECALLING FIRM
Pain Free by Nature, 1460 Masters Dr., Woodland Park, CO 80863
REASON FOR RECALL
Labeling: Product Contains Undeclared Diclofenac and Methocarbamol
 
PRODUCT
Fluoxetine Capsules USP, 20 mg, supplied in 100, 500, 1000 and 2000 count bottles, Rx, NDC 50111-648-01, 50111-648-02, 50111-648-03, 50111-648-44
Fluoxetine Capsules USP, 10 mg, supplied in 100 count bottles, Rx, 50111-647-01
CODE
6A209116 6A209117 6A209118 6A209119 6A209120 6A209124 6A211139 6A211140 6A211141 6A211143 6A211144 6A211145 6A211146 6A211147 6A211148 6A211149 6A211150 6A211151 6A211152 6A211153 6A211154 6A212083 6A212084 6A212085 6A212086 6A212087 with expiration dates 9/2015, 11/2015, and 12/2015.
RECALLING FIRM
Teva Pharmaceuticals USA, Horsham, PA
REASON FOR RECALL
Complaints of capsule odor
 
PRODUCT
etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 mL Single Dose Vials (NDC 0069-0006-02), 10 x 10 mL vials per carton (NDC 0069-0006-01) and b) 40 mg/20 mL (2 mg/mL) 20 mL Single Dose Vials (NDC 0069-0006-04), 10 x 20 mL vials per carton (NDC 0069-0006-03), Rx only, Distributed by Pfizer Labs; Division of Pfizer Inc., New York, NY  10017.
CODE
Lot #: a) 5000983, 5000986, Exp 08/14; 5001023, Exp 09/14; b) 5000927, 5000931, 5000936, 5000942, 06/14; 5001012, 5001040, Exp 09/14; 5001071, Exp 10/14
RECALLING FIRM
Agila Specialties Private Ltd., Bangalore, Karnataka, India
REASON FOR RECALL
Presence of Particulate Matter: Potential for small black particles to be present in individual vials, the potential for missing lot number and/or expiry date on the outer carton and the potential for illegible/missing lot number and expiry on individual vials.  
 
PRODUCT
Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, Bentonville, AR 72716; Manufactured by: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC 68645-130-54, UPC 3 68645 13054 5.
CODE
Lot numbers: 131328, Exp 08/15; 131634, Exp 09/15; and 131833, Exp 11/15
RECALLING FIRM
Legacy Pharmaceutical Packaging
REASON FOR RECALL
Sub-recall of Teva Pharmaceuticals USA recall due to complaints of capsule odor.
 
 
  •  Pending recalls for the March 12, 2014 Enforcement Report 
PRODUCT
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11
CODE
Lot number: C903799, Exp 05/15
RECALLING FIRM
Baxter Healthcare Corp., Deerfield, IL
REASON FOR RECALL
Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch
 
 
  • Pending recalls for the March 5, 2014 Enforcement Report
PRODUCT
Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York  11747, NDC 0168-0004-80, UPC 3 0168-0004-80 8.
CODE
Lot #: 485P, 486P, 487P, 488P, Exp 06/15; 638P, 639P, 640P, Exp 07/15; 753P, 754P, 755P, Exp 08/15; 898P, 756P, 757P, 758P, 899P, 900P, 901P, 902P, Exp 09/15
RECALLING FIRM
Fougera Pharmaceuticals Inc., Melville, NY
REASON FOR RECALL
Labeling: Error on Declared Strength:
 
  • Pending recalls for the February 26, 2014 Enforcement Report
PRODUCT
Alprazolam Extended-Release Tablets, 1 mg USP 500 tablets, Rx Only, NDC 0228-2031-50
CODE
Lot # 1826E131, Exp 04/2015
RECALLING FIRM
Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA
REASON FOR RECALL
Failed Tablet/Capsule Specification: Tablet Erosion
 
PRODUCT
Lansoprazole Delayed Release Capsules, 15 mg 14 count. (multiple NDC’s distributed by private labels)
CODE
79305114A; 79305114B; 79305114C; 79305114D; 79305114E; 79305114F; Exp 05/2015
RECALLING FIRM
Dr. Reddy's Laboratories, Inc. 107 College Road East Princeton, NJ 08540
REASON FOR RECALL
Microbial contamination of non-sterile product: Out-of-specification microbial results were obtained at the initial stability interval for Lansoprazole Delayed Release Capsules.
 
PRODUCT
Gelnique (oxybutynin chloride) Gel 10%, Physician Sample Clamshell, 7 Sachets, Rx Only. NDC 52544-084-77
CODE
Lot number: 514656.  Exp 3/14
RECALLING FIRM
Watson Laboratories, Inc (Actavis Pharma, Inc), 575 Chipeta Way, Salt Lake City, UT 84108
REASON FOR RECALL
Subpotent Drug: Packaging was crushed during shipment, causing drug to lose potency.
 
PRODUCT
Atripla (efavirenz, emtricitabine, and tenofovirdisoproxil fumarate) Tablet, Film Coated, 30 Count Bottles. Rx Only. NDC:15584-0101-1.
CODE
Lot Number: 002390, 002400, Expiry: 02/2017.
RECALLING FIRM
Gilead Sciences, 333 Lakeside Drive, Foster City, CA 94404, on behalf of Brystol-Myers Squibb & Gilead Sciences, LLC.
REASON FOR RECALL
Presence of Particulate Matter: Red Silicone Rubber Particulates are Present in Drug.
 
PRODUCT
a) DermOtic Oil 0.01% Ear Drops
b) Derma-Smoothe/FS 0.01% Scalp Oil
c) Derma-Smoothe/FS 0.01% Body Oil
d) ROYAL PHARMACEUTICALS Derma-Smoothe/FS 0.01% Body Oil
e) ROYAL PHARMACEUTICALS Derma-Smoothe/FS 0.01% Scalp Oil
f) ROYAL PHARMACEUTICALS DermOtic Oil 0.01% Ear Drops
g) SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Scalp Oil
h) SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Body Oil
i) SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil Ear Drops
CODE
a) 12H028B Exp. 1/14
b) 12J030C Exp. 03/14; 12L041C Exp. 05/14
c) 13D010A Exp. 10/14
d) 13E013A Exp. 11/14
e) 13E014A Exp. 11/14; 13F02C Exp. 12/14
f) 13F015B Exp. 12/14; 13G023B Exp. 01/15
g) 13F015C Exp. 12/14
h) 13F016A Exp. 12/14
i) 13F017B Exp. 12/14; 13F020B Exp. 12/14
RECALLING FIRM
Hill Dermaceuticals, Inc., Sanford, FL 32773
REASON FOR RECALL
Subpotent Drug: fluocinolone acetonide,
 
 
  • Pending recalls for the February 19, 2014 Enforcement Report

 

PRODUCT
Carisoprodol Tablets USP, 350 mg, unit dose packages of 100 tablets (10x10 Cards), Rx only, NDC 51079-819-20
CODE
3037463, Expires 2/2014; 3039466, Expires 3/2014; 3040644, Expires 4/2014; 3043463, Expires 6/2014; 3049568, Expires 3/2015
RECALLING FIRM
Mylan Instituitional, Inc., dba UDL Laboratories, Rockford, IL
REASON FOR RECALL
Failed Impurity/Degradation Specification; out of specification result for Organic Impurities
 
 
PRODUCT
Metformin HCl Extended Release Tablets, USP, 500 mg, Rx only, NDC 62756-142-02
CODE
Batch JKM2433A, Mfg Date 04/2013; Exp 03/2016
RECALLING FIRM
Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI
REASON FOR RECALL
Presence of Foreign Tablets/Capsules; bottles of Metformin tablets found to contain Gabapentin tablets
 
 
PRODUCT
Various Dietary Supplement products marketed for weight loss
CODE
All lots and codes
RECALLING FIRM
MyNicNaxs, Inc., Deltona, FL
REASON FOR RECALL
Marketed without an Approved NDA/ANDA; products found to contain Sibutramine, Phenolphthalein of a combination of both

 

  • Pending recalls for the January 29, 2014 Enforcement Report

 

PRODUCT           
Pro ArthMax dietary supplement tablets, 120 count bottle
CODE:  
ALL LOTS Exp: 03/13, 01/16, 04/16, 08/2016, and 10/2016.
RECALLING FIRM
HUMAN SCIENCE FOUNDATION, Gardena, CA
REASON FOR RECALL 
Marketed without an Approved NDA/ANDA: The product has been found to contain the undeclared active pharmaceutical ingredients Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin, making it an unapproved new drug.
 
PRODUCT
Preservative-Free Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials (NDC 0409-2066-05)
CODE
Lot number 32135DD, Exp 08/15
RECALLING FIRM
Hospira Inc., Lake Forest, IL
REASON FOR RECALL
Presence of Particulate Matter:The product may contain particulates from iron embedded in the glass container coming in contact with product solution.
 
PRODUCT
Dobutamine Injection, USP, 250 mg per 20 mL, 20 ML Single -dose, Fliptop Vial (NDC 0409-2344-02)
CODE
Lot number 27-352-DK, Exp 03/15
RECALLING FIRM
Hospira Inc., Lake Forest, IL
REASON FOR RECALL
Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution
 
PRODUCTS
a)      Herbal Give Care Esbelin siloutte capsules
b)      Herbal Give Care Esbelin Siloutte Té
c)       Herbal Give Care Esbelder Siloutte capsules
d)      Herbal Give Care Esbelder Man capsules
e)      Herbal Give Care Esbelder Fem capsules
CODE
All codes
RECALLING FIRM
Herbal Give Care Llc, Grand Prairie, TX
REASON FOR RECALL
Marketed Without An Approved NDA/ANDA: The products have been found to contain undeclared Sibutramine, N-Desmethylsibutramine, and N-di-Desmethylsibutramine. N-Desmethylsibutramine and N-di-Desmethylsibutramine are analogues of sibutramine. Sibutramine was once a previously available FDA-approved drug used as an appetite suppressant for weight loss, that was withdrawn from the United States market in October 2010 for safety reasons and phenolphthalein was once an ingredient used in over-the counter laxatives, but because of concerns of carcinogenicity is not currently approved for marketing in the United States, making these products unapproved new drugs.
 
PRODUCTS
a) Dr. Sheffield Triple Antibiotic Ointment; 0.33oz
b) Family Wellness Triple Antibiotic Ointment. NET WT 1 OZ
c) Dr. Sheffield Triple Antibiotic Ointment; NET WT 1 OZ
d) Dollar General Triple Antibiotic Ointment; NET WT 1 OZ
CODE
a) 20154EXP12/13, 20153EXP12/13, 20152EXP12/12, 20151EXP12/11, 20093EXP12/13, 20092EXP12/13, 20091EXP12/13, 20085EXP12/13, 20084EXP12/13, 20083EXP12/13, 20082EXP12/13, 20073EXP 12/13, 20074EXP 12/13, 20075EXP 12/13, 20081EXP12/13
b) 20022 EXP 12/13, 20031 EXP 12/13, 20032EXP 12/13, 20041 EXP 12/13, 20042EXP 12/13, 20051 EXP 12/13, 20052EXP 12/13, 20061EXP 12/13, 20071EXP 12/13, 20072EXP 12/13
c) 20021 EXP 12/13
d)  20221EXP04/14
RECALLING FIRM
Faria Limited LLC dba Sheffield Pharmaceuticals, New London, CT
REASON FOR RECALL
Microbial Contamination of Non-Sterile Products: During routine QC monitoring of the firm's environment, elevated counts of gram positive rods were recovered.
 
PRODUCT
Burn 7 Capsules
CODE
MFD: 07.18.2013
RECALLING FIRM
Deseo Rebajar, Fajardo, PR 00738
REASON FOR RECALL
Marketed without and Approved NDA/ANDA: FDA lab results found the product to contain undeclared sibutramine. Sibutramine was once a previously available FDA-approved drug used as an appetite suppressant for weight loss, that was withdrawn from the United States market in October 2010 for safety reasons, making this product an unapproved new drug.
 
PRODUCT
a)      Dr. Ming's Chinese Capsule (Ginger 50 mg, Camellia Sinensis 50 mg, Malus Domestica 50 mg, Propetary Blend 300 mg Cynara Scolymus, Hoodia, Sirulina, Chitosan, 60-count bottles, Distributed by Natural Products, Doral, FL 33178.
b)      Magic Slim capsules (LingZhi, Ebony, Fox-nut, Tuckahoe, Seman Pruni, Dioscoreae, Wheat Germ, Nature Substance), 60-countt bottles.
c)       Dream Body Slimming Capsule (Chinese bitter orange 24%, Cassia Seed 18%, Aloe 16%, Lotus Leaf Extract 12%, Medical Amylum 30%), 350 mg, 30-count bottles, Made in China (Beijing).
CODE
a)      Lot #: 18 04 12, Exp 17 04 14
b)      No lot code information or exp date on packaging.
c)       Lot # 20130328, Exp 3/27/15
RECALLING FIRM
Slim Beauty USA, Kearney, NE
REASON FOR RECALL
Marketed Without An Approved NDA/ANDA: The products contain undeclared sibutramine and/or phenolphthalein. Sibutramine was once a previously available FDA-approved drug used as an appetite suppressant for weight loss, that was withdrawn from the United States market in October 2010 for safety reasons and phenolphthalein was once an ingredient used in over-the counter laxatives, but because of concerns of carcinogenicity is not currently approved for marketing in the United States, making these products unapproved new drugs.
 
 
  • Pending recalls for the January 22, 2014 Enforcement Report 

 

PRODUCT
Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, packaged in 5 Units x 20 mL per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
CODE
Lot #: 27-568-DJ*, Exp 03/15, Note * may be followed by 01
RECALLING FIRM
Hospira Inc., Lake Forest, IL
REASON FOR RECALL
Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate matter which could result in the potential for small glass flakes or embedded metal particulate to become dislodged into the solution.

 

  • No Pending recalls for the January 15th, 2014 Enforcement Report
  • No Pending recalls for the January 8th , 2014 Enforcement Report
  • No pending recalls for the January 1st, 2014 Enforcement Report

 

  • Pending recalls for the December 25th, 2013 Enforcement Report

 

PRODUCT
a)      Dextrose 50% in sterile water, 50 mL single dose vial compounded by Specialty Medicine Compounding Pharmacy, South Lyon, MI
b)      All sterile products compounded by Specialty Medicine Compounding Pharmacy, South Lyon, MI. See Firm Press Release for attached list of products.
CODE
All unexpired lots of the above attached link of products.
RECALLING FIRM
Specialty Medicine Compounding Pharmacy, South Lyon, MI
REASON FOR RECALL
a)      Non-sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product
b)      Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded under the same conditions as another product found to be non-sterile and therefore sterility cannot be assured.
 
PRODUCT
a)      5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product code 2B0089, NDC 0338-0017-38.
b)      0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers (Product code 2B1308, NDC 0338-0049-31) and b) 100 mL Single dose VIAFLEX plastic containers (Product code 2B1302, NDC 0338-0049-18) and (Product code 2B1309, NDC 0338-0049-38), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
CODE
a)      Lot #: P285288, Exp 11/13
b)      Lot #: a) P297283, Exp 08/14; b) P292326, Exp 04/14; P293993, Exp 05/14; and P293514, Exp 04/14
RECALLING FIRM
Baxter Healthcare Corp., Deerfield, IL
REASON FOR RECALL
Presence of Particulate Matter: various particulate matter found in the solution.
 
  • Pending recalls for the December 18th, 2013 Enforcement Report

 

PRODUCT
KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-30, UPC 3 0168-0099-30 9.
CODE
Lot #: 495P, Exp 07/14
RECALLING FIRM
Fougera Pharmaceuticals Inc., Melville, NY
REASON FOR RECALL
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
 
PRODUCT
Folic Acid Injection, USP 5 mg / mL, 10 mL Multiple Dose Vial  
CODE
Lot 6104649, Exp. 02/14 61047869 Exp. 03/14, 6105069 Exp. 04/14
RECALLING FIRM
Fresenius Kabi USA, LLC, Lake Zurich, IL
REASON FOR RECALL
Failed Impurities/Degradation Specifications: out-of-specification result reported for impurities at the 15 and 14 month stability test station
 
PRODUCT
Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 metered sprays, 8.7 g inhaler, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Delivery Systems, Northridge, CA 91324, NDC 59310-210-12, UPC 3 59310 21012 9.
CODE
Lot #: 120004, Exp 01/14; 120095, 120131, 120131 2, Exp 03/14; 120271, Exp 07/14; 120351, Exp 08/14
RECALLING FIRM
Teva Pharmaceuticals USA, Horsham, PA
REASON FOR RECALL
Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves. 
 
PRODUCT
Fluconazole Oral Suspension, 10 mg/mL, in a plastic 35 mL bottle, NDC 0093-5414-95
CODE
all lots with expiration date through 5/2015: V10316 11/13 V10317 11/13 V10320 11/13 V10321 11/13 V20087 2/14 V20089 2/14 V20093 2/14 V20094 2/14 V20086 2/14 V20118 3/14 V20119 3/14 V20147 3/14 V20148 3/14 V20152 4/14 V20154 4/14 V20155 4/14 V20180 4/14 V20181 4/14 V20182 4/14 V20203 5/14 V20204 5/14 V20233 5/14 V20234 5/14 V20273 6/14 V20274 6/14 V20275 6/14 V20293 8/14 V20294 8/14 V20321 9/14 V20322 9/14 V20323 9/14 V20324 9/14 V20325 9/14 V20326 9/14 V20327 9/14 V20369 10/14 V20370 10/14 V20410 11/14 V20411 11/14 V20412 11/14 V30009 12/14 V30010 12/14 V30011 12/14 V30056 01/15 V30120 2/15 V30122 2/15 V30123 2/15 V30163 3/15 V30164 3/15 V30165 3/15 V30190 3/15 V30249 5/15 V30250 5/15
RECALLING FIRM
Teva Pharmaceuticals USA Inc., Sellersville, PA
REASON FOR RECALL
Failed Stability Specification: below specification for preservative content
 
PRODUCT
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj, 50 mL Multiple–Dose Fliptop Vials, Rx only, NDC 0409-9046-01
CODE
Lot #32-484-EV and 32-485-EV
RECALLING FIRM
Hospira, Inc., Lake Forest, IL
REASON FOR RECALL
Lack of Assurance of Sterility; Due to an equipment failure which occurred during manufacturing resulting in a potential breach in the aseptic process
 
  • Pending recalls for the December 11th, 2013 Enforcement Report 

 

PRODUCT
1 Believe in Yourself Strawberry Scent Antibacterial Hand Sanitizer, 1 fl oz bottles, Red 40 (Cl 16035)
2 Share a Smile Mixed Berry Scent Antibacterial Hand Sanitizer, 1 fl oz bottles, Red 40 (Cl 16035, Blue 1 (Cl42090)
3 Shine from Within Blueberry Scent Antibacterial Hand Sanitizer, 1 fl oz bottles, Red 40 (Cl 16035)
4 Girls can change the World Green Apple Scent Antibacterial Hand Sanitizer, 1 fl oz bottles, Yellow 5 (Cl     19140) Blue 1 (Cl 42090)
5 FOLLOW YOUR DREAMS! Chocolate Scent Antibacterial Hand Sanitizer, 1 fl oz bottles, Red 40 (Cl 16035), Blue 1 (Cl 42090)
6 TODAY IS AWESOME! Cotton Candy Scent Antibacterial Hand Sanitizer 1 fl oz bottles, Red 40 (Cl 16035), Blue 1 (Cl 42090)
7 LIFE IS SWEET! Vanilla Scent Antibacterial Hand Sanitizer, 1 fl oz bottles, Red 40 (Cl 16035)
8 I love my BFF Watermelon Scent Antibacterial Hand Sanitizer, 1 fl oz bottles, Red 40 (Cl 16035)
9 I Love Sleepovers Grape Scent Antibacterial Hand Sanitizer, 1 fl oz bottles, Red 40 (Cl 16035), Blue 1 (Cl 42090)
10 I Love to Shop Peach Scent Antibacterial Hand Sanitizer, 1 fl oz bottles, Red 40 (Cl 16035), Blue 1 (Cl 42090)
11 Lemon Scent Antibacterial Hand Sanitizer, 1 fl oz bottles
12 Grapefruit Scent Antibacterial Hand Sanitizer, 1 fl oz bottles
13 GIRLS ROCK Vanilla Scent Antibacterial Hand Sanitizer, 1 fl oz bottles
14 I MUSTACHE YOU TO BE MY BFF Cotton Candy Scent, Antibacterial Hand Sanitizer, 1 fl oz bottles
15 I LOVE BACON Vanilla Scent Antibacterial Hand Sanitizer, 1 fl oz bottles
16 YOU CAN’T HANDLE THIS, Grape Scent Antibacterial Hand Sanitizer, 1 fl oz bottles
17 Yum Yum Bubble Gum Justice" BUBBLEGUM Scent, Antibacterial Hand Sanitizer, 1 fl oz bottles
18 BFF’s are COOL! Cherry Scent, Antibacterial Hand Sanitizer, 1 fl oz bottles
CODE
1 Style #190782 & 190864
2 Style #190783 & 190865
3 Style #190784 & 190866
4 Style #190785
5 Style #190786 & 190867
6 Style #190787 & 190868
7 Style #190788
8 Style #190844 & 190869
9 Style #190845 & 190870
10 Style #190846
11 Style #190847 &190871
12 Style #190848 & 190872
13 Style #191272
14 Style #191273
15 Style #191274
16 Style #191276
17 Style #191278
18 Style #191365
RECALLING FIRM
Tween Brands Inc., New Albany, OH
REASON FOR RECALL
Labeling; Label Error on Declared Strength; The labels states that the products contain 62% ethyl alcohol, but the ethyl alcohol content is 20%.
 
 
PRODUCT
Endometrin (progesterone) Vaginal Insert, 100 mg, 21 count carton, NDC 55566-6500-3
CODE
Lot Number:Expiry Date - 0804.182B-1:07/14; 0804.183B-1:07/14; 0804.185A-1:08/14; 0804.186B-1:08/14; 0804.187B-1:08/14; 0804.187-2:08/14; 0804.189A-1:08/14; 0804.191B-1:09/14; 0804.193B-1:09/14; 0804.194B-1:09/14; 0804.200C-1:10/14 and 0804.200C-2:10/14.
RECALLING FIRM
Ferring Pharmaceuticals Inc., Parsippany, NJ
REASON FOR RECALL
Discoloration; due to prolonged heat exposure during packaging
 
  • No pending recalls for the December 4th, 2013 Enforcement Report

 

  • Pending recalls for the November 27th, 2013 Enforcement Report

 

PRODUCT
GREENSTONE BRAND Nifedipine tablets, 90 mg Rx only, 100 count, blister packs,   NDC 59762-6692-8
CODE
Lot V110079
RECALLING FIRM
Greenstone LLC, Peapack, NJ 07997
REASON FOR RECALL
Labeling: Incorrect or Missing Lot and/or Exp Date
 
PRODUCT
1)    Glycopyrrolate tablets USP 1 mg. Rx Only, 100 count bottle, NDC 0143-1250-01;
2)    Glycopyrrolate tablets USP 2 mg  100 count bottle NDC 0143-1251-01;
3)    Ethambutol Hydrochloride tablets, USP, 400 mg Rx only, bottles and blister packs a) 10-count blister packs NDC 61748-014-11, b) 60-count bottles NDC 61748-014-06, c) 90-count bottles NDC 61748-014-09, d) 100-count bottles NDC 61748-014-01, e) 1000-count bottles NDC 61748-014-10;
4)    Naproxen Tablets, USP 500 mg, Rx Only, a) 100 count bottles, NDC 0143-1348-01; b)  500 count bottles, NDC 0143-1348-05;
5)    Mefloquine Hydrochloride Tablets, 250 mg Rx Only, 25 count bottle NDC 0143-1282-22;
6)    Primidone Tablets, USP 250 mg, Rx only, a) 100 count bottle NDC 0143-1484-01; b) 1000 count bottle NDC 0143-1484-10
CODE
1) Lots 70197A, 70198A, 70199A, 70200A, 70201A, 70202A, Exp 05/14
2) Lots 69467A, 69468A, 69469A, Exp 05/14
3) a) Lots 69967A, Exp 03/16; b) 69967B, Exp 03/14; c) 69968C, Exp 03/16; d) 69968D, Exp 03/16; e) 69967C, 69968A, Exp 03/16
4) a) Lots 69739A, 69740A, Exp 11/15; 70146A, Exp 01/16; b)  Lots 69739B, 69740B, Exp 11/15; 69741A, 70148A, Exp 12/15
5) Lots 70044A, 70045A, Exp 04/14
6) a) and b) Lot 69821, Exp 01/16
RECALLING FIRM
West-Ward Pharmaceutical Corp, Eatontown, NJ 07724
REASON FOR RECALL
Out of Specification results found during the re-testing of raw material, Kollidon-30 (povidone), an excipient used in the manufacture of these products.
 
PRODUCT
Oncaspar (pegaspargase) Injection, 750 IU/mL, 5 mL Vial, Rx only, sigma-tau Pharmaceuticals, Inc., 9841 Washingtonian Blvd., Gaithersburg, MD  20878, NDC 54482-301-01
CODE
Lots 3012A, Exp 11/06/13; 3013A, Exp 11/09/13;  3014A, Exp 12/30/13
RECALLING FIRM
Sigma-Tau Pharmaceuticals, Inc., Gaithersburg, MD 20878
REASON FOR RECALL
Lack of Assurance of Sterility
 
PRODUCT
Tacrolimus Capsules, USP, 0.5 mg, 100 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd. For Sandoz Inc., Princeton, NJ  08540, NDC 0781-2102-01
CODE
Lots DE9898, DE9900, DE9903, DE9908, DE9911, Exp 06/14
RECALLING FIRM
Sandoz Incorporated, Broomfield, CO 80020
REASON FOR RECALL
Cross Contamination with Other Products
 
PRODUCT
  1. Rhino 5 capsules, 1-count blister packs, English UPC 6 10708 10730 9, Spanish UPC 6 10708 10729 3
  2. MaXtremeZEN capsules, 1-count blister packs, UPC 6 10079 52468 2
  3. eXtenZone capsules, 1-count blister packs, UPC 6 89076 49126 6
CODE
  1. Lot #: KWAKPMC030505175957019, Exp 12/16
  2. Lot #: JBP-L-1270-70, Exp 12/16
  3. Lot #: KWAKPMC03050517, Exp 12/16
RECALLING FIRM
SS Wholesale Inc. dba Jobbers Wholesale, Paramount, CA
REASON FOR RECALL
Marketed Without An Approved NDA/ANDA: FDA analysis found Rhino 5, MaXtremeZEN, and eXtenZone which are marketed as dietary supplements to contain undeclared desmethyl carbondenafil and dapoxetine.  Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making these products unapproved new drugs.  Dapoxetine is an active ingredient not approved by the FDA.
 
PRODUCT
VitaliKor Ready When you Are, male enhancement capsules; Dietary Supplement. 40-count bottles, UPC: 6 0913 35159 4
CODE
LOT K58Q Exp. 01/16; LOT F50Q Exp. 07/16
RECALLING FIRM
Vitality Research Labs, LLC, Las Vegas, Nevada 89148
REASON FOR RECALL
Marketed without an Approved NDA/ANDA: FDA lab analysis found that VitaliKOR has been found to contain undeclared vardenafil and tadalafil; both active ingredients in FDA approved products used to treat male erectile dysfunction, making this product an unapproved new drug.
 
  • Pending recalls for the November 20th, 2013 Enforcement Report

 

PRODUCT
Sertraline HCl Tablets, 25 mg, 30 count bottles, Rx only, NDC 59762-4960-1
CODE
Lot SASA12001-A, exp. date 06/2015; Lot SASA12001-B, exp. date 06/2015; Lot SASA13001-A, exp. date 02/2016; Lot SASA13002-A, exp. date 02/2016
RECALLING FIRM
Greenstone LLC, Peapack, NJ    
REASON FOR RECALL
Incorrect Expiration date; lot was distributed with a 36 month expiry instead of a 24 month expiry
 
PRODUCT
Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6
CODE
Drug Product Lots 10010 and 10001; Finished Product Lots 10010A and 10001-1
RECALLING FIRM
Alexion Pharmaceuticals, Inc., Cheshire, CT
REASON FOR RECALL
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
 
PRODUCT
  1. Acetaminophen suspension liquid, 160 mg/5 mL, dye-free cherry flavor, co-packaged with an oral dosing syringe in a carton and sold under the following: a) equaling infants' pain & fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by SUPERVALU Inc., Eden Prairie, MN 55344, NDC 41163-590-16, UPC 0 41163 48657 7; b) Up & Up dye free infants' pain and fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-590-16, UPC 3 70030 62529 1; c) equate Infants' Pain & Fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-590-16, UPC 6 81131 00185 4; d) Meijer Infants' Pain & Fever acetaminophen oral suspension, 2 FL OZ (59 mL) bottle, Dist. By Meijer Distribution, Inc., 2929 Walker Ave. NW, Grand Rapids, MI 49544, NDC 41250-590-16, UPC 7 13733 31376 6; e) Walgreens infants' Dye-Free Pain & Fever acetaminophen oral suspension, 2 FL OZ (59 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0590-16, UPC 3 11917 13222 8; f) Kroger Infants' Pain & Fever suspension liquid, 4 FL OZ (118 mL) bottle, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-590-26, UPC 0 41260 36738 0; g) Kroger Infants' Pain & Fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-590-16, UPC 0 41260 35829 6; h) Publix Infants' painrelief acetaminophen suspension liquid, 2 FL OZ (59 mL), Distributed By Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 55062-590-16, UPC 0 41415 39573 2; i) CareOne Infants' Dye-Free Pain Relief acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed By Foodhold U.S.A., LLC, Landover, MD 20785, NDC 41520-590-16, UPC 3 41520 31006 5; j) Harmon FaceValues Infants' Pain & Fever acetaminophen suspension Liquid, 2 FL OZ (59 mL), Distributed by Harmon Stores, Inc., 650 Liberty Ave., Union, NJ 07083 USA, UPC 3 70030 51018 4
  2. Acetaminophen suspension liquid, 160 mg/5 mL, cherry flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) leader Infants' Pain & Fever acetaminophen suspension, Distributed by Cardinal Health, Dublin, Ohio 43017, NDC 37205-577-16, UPC 0 96295 12095 0; b) Walgreens infants' Pain & Fever acetaminophen oral suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0161-16, UPC 3 11917 13221 1; c) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-161-16, UPC 0 41260 35831 9; d) H-E-B Pain & Fever acetaminophen suspension Infants', Made With Pride & Care For H-E-B, San Antonio, TX 78204, NDC 37808-161-16, UPC 0 41220 88066 9; e) Babies R Us Infants' Pain & Fever acetaminophen suspension, Distributed by Toys R Us, Inc., Wayne, NJ 07470, NDC 51334-161-16, UPC 7 17851 20094 6; f) healthy accents infants' pain & fever acetaminophen suspension liquid, Distributed By: DZA Brands, LLC, Salisbury, NC 28147/Scarborough, ME 04074, NDC 55316-161-16, UPC 7 25439 95814 1; g) Health Mart Pharmacy infants' pain & fever acetaminophen suspension liquid, Distributed by McKesson, One Post Street, San Francisco, CA 94104, NDC 62011-0002-1, UPC 0 52569 13248 7
  3. Acetaminophen suspension liquid, 160 mg/5 mL, dye-free grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) TopCare Infants' Pain & Fever acetaminophen, Distributed by Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-766-16, UPC 0 36800 34650 5; b) Meijer Infants' Pain & Fever acetaminophen oral suspension, Dist. By Meijer Distribution, Inc., 2929 Waler Ave. NW, Grand Rapids, MI 49544, NDC 41250-766-16, UPC 7 13733 31403 9; c) Rite Aid infants' fever reducer & pain reliever oral suspension, Distributed By: Rite Aid, 30 hunter Lane, Camp Hill, PA 17011, UPC 0 11822 35341 0; d) Walgreens infants' Dye-Free Pain & Fever acetaminophen suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0766-16, UPC 3 11917 13223 5; e) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-766-16, UPC 0 41260 35830 2
  4. Acetaminophen suspension liquid, 160 mg/5 mL, grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) equate Infants' Pain & Fever acetaminophen suspension liquid, Distributed by: Wal-Mart Stores, Inc., Bentonville, AZ 72716, NDC 49035-946-16, UPC 0 78742 09060 3; b) leader Infants' Pain & Fever acetaminophen suspension, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-576-16, UPC 0 96295 12093 6; c) TopCare Infants' Pain & Fever acetaminophen, Distributed by Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-946-16, UPC 0 36800 34645 1; d) Walgreens infants' Pain & Fever acetaminophen oral suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0946-16, UPC 3 11917 13225 9; e) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-946-16, UPC 0 41260 35832 6
CODE
  1. 2 FL OZ Lot #: 3HK0564, Exp 06/15; 3HK0672, Exp 06/15; 3JK0594, Exp 07/15; 3JK0595, Exp 08/15; 3KK0815, Exp 08/15; 4 FL OZ Lot #: 3GK0645, Exp 06/15
  2. Lot #: 3HK0671, Exp 06/15; 3JK0610, Exp 07/15; 3KK0606, Exp 08/15
  3. Lot #: 3GK0704, Exp 04/15; 3JK0597, Exp 08/15; 3KK0359, Exp 08/15
  4. Lot #: 3JK0653, Exp 07/15; 3JK0433, Exp 07/15; 3KK0817, Exp 08/15; 3JK0673, Exp 08/15; 3KK0494, Exp 08/15; 3KK0360, Exp 08/15
RECALLING FIRM
L. Perrigo Co., Allegan, Michigan
REASON FOR RECALL
Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.
 
PRODUCT
Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe, packaged in 30 single-use PRE-FILLED Syringes and 33 Alcohol Preps (Swabs) per carton, Rx only, Marketed by: Teva Neuroscience, Inc., Kansas City, MO 64131; Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 68546-317-30, UPC 3 68546 31730 4.
CODE
Lot X06381, Exp 10/14
RECALLING FIRM
Teva Pharmaceuticals USA, Horsham, PA
REASON FOR RECALL
Presence of Particulate Matter: A foreign particle found in a pre-filled syringe.
 
PRODUCT
Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.
CODE
Lot 25220DD, Exp 1JAN2015
RECALLING FIRM
Hospira Inc., Lake Forest, IL
REASON FOR RECALL
Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.
 
PRODUCT
Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59
CODE
Lot # 161304B, Exp. OCT 2013
RECALLING FIRM
Boehringer Ingelheim Roxane Inc., Columbus, OH
REASON FOR RECALL
Resuspension Problems: Recalled lot did not meet resuspendability requirements.
 
PRODUCT
Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 100-count bottle (NDC 0054-0097-25), Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216
CODE
Lot #: a) 259666A, Exp. MAR 2014; b) 259666B, Exp. MAR 2014
RECALLING FIRM
Boehringer Ingelheim Roxane Inc., Columbus, OH
REASON FOR RECALL
Subpotent Drug
 
PRODUCT
Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-281-01, UPC 3 68180 28101 6.
CODE
Lot #: 3122856, Exp 05/14
RECALLING FIRM
Lupin Pharmaceuticals Inc., Baltimore, MD
REASON FOR RECALL
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
 
PRODUCT
Paclitaxel Injection (semisynthetic) 300mg/5ml ;( 6mg/ml) Multiple Dose Vial; (NDC 63323-763-50), Rx Only
CODE
Lot Numbers and Expiration Dates: 871ZA00201, 11/2013; 871ZA00301, 11/2013; 871ZA00302, 11/2013; 871ZA00401, 11/2013; 871ZA00402, 11/2013; 872ZA00101, 12/2013; 872ZA00201, 12/2013; 872ZA00301, 12/2013; 872ZA00401, 12/2013; and, 872ZA00501, 12/2013.
RECALLING FIRM
Fresenius Kabi USA, LLC, Lake Zurich, IL
REASON FOR RECALL
Labeling: Missing text on the product insert in the “Clinical Studies” and “Specific Adverse Events” sections. Important information related to the efficacy of the Phase 3 Second-Line Ovarian Carcinoma Study and adverse event information for Renal and Gastrointestinal systems for the recalled lots was observed to be missing from the package insert.
 
PRODUCT
Acyclovir Tablets USP 800 mg (650505-5307), Rx Only; Manufactured for Apotex Inc., Toronto, Canada
CODE
Lot # KF2199 Expiration date: 07/2015
RECALLING FIRM
Apotex Inc., Toronto, CA
REASON FOR RECALL
Presence of Particulate Matter: one tablet within the bottled was found to contain a blue plastic-like material embedded in the side of the tablet
 
PRODUCT
Daunorubicin Hydrochloride Inj., 20 mg/4 mL (5 mg/mL), Rx only, NDC 0703 4233 11
CODE
Lot number EXP Carton NDC Vial NDC 31314801B 2/2014 0703-5233-13 0703-5233-11 31314990B 2/2014 0703-5233-13 0703-5233-11 31314991B 2/2014 0703-5233-13 0703-5233-11 31315014B 2/2014 0703-5233-13 0703-5233-11 31315155B 6/2014 0703-5233-13 0703-5233-11 31315279B 6/2014 0703-5233-13 0703-5233-11 31315837B 10/2014 0703-5233-13 0703-5233-11 31315921B 10/2014 0703-5233-13 0703-5233-11 31316029D 12/2014 0703-5233-13 0703-5233-11 31316029C 12/2014 0703-5233-93 0703-5233-91
RECALLING FIRM
TEVA Pharmaceuticals USA, Horsham, PA
REASON FOR RECALL
Presence of Particulate Matter; degradant of the product
 
PRODUCT
Fosinopril sodium and Hydrochlorothiazide Tablets, 10 mg/12.5mg, 100 count bottles, Rx only, NDC 0185-0341-01
CODE
Lot CU0856, Exp 4/2014
RECALLING FIRM
Sandoz Inc., Wilson, NC 27893-8143
REASON FOR RECALL
Subpotent; hydrochlorothiazide
 
PRODUCT
Alprazolam Orally Disintegrating Tablets, USP 2 mg, Rx only, NDC 0228-4025-11
CODE
Lot 59380831, exp 5/2014
RECALLING FIRM
Actavis Elizabeth, LLC, Elizabeth, NJ 07202-1106
REASON FOR RECALL
Failed Tablet Specifications
 
PRODUCT
Aldactone (spironolactone) Tablets, USP, 100 mg, 100 count bottles, Rx only, Distributed by G.D. Searle, Division of Pfizer, Inc., NDC 0025-1031-31
CODE
V121573
RECALLING FIRM
Pfizer US Pharmaceutical Group, New York, NY
REASON FOR RECALL
Marketed without an Approved NDA/ANDA; This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.
 
  • No pending recalls for the November 13th, 2013 Enforcement Report.

 

  • No pending recalls for the November 6th, 2013 Enforcement Report.

 

  • Pending recall for the October 30th, 2013 Enforcement Report

 

PRODUCT
a)    Quick Thin (citrus aurantium extract, sweet potato fiber, cyamopsis gum powder, alfalfa, mulberry leaf, guarana, spirulina) capsules, 400 mg, 30-count bottle
b)    Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear seed, spirulina, starch, kola nut) capsules, 400 mg, 30-count bottles
CODE
a)    Lot 10032011, Exp 10/14
b)    Lot 10092011, Exp 2014
RECALLING FIRM
Bethel Nutritional Consulting, Inc., New York, NY
REASON FOR RECALL
Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of sibutramine and/or its analogues and phenolphthalein. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs

 

  • Pending recalls for the October 23rd, 2013 Enforcement Report

 

PRODUCT
Valacyclovir Hydrochloride Tablets 500 mg, 100 count unit dose packs, Rx only, NDC 68084-633-01
CODE
Lot 130007, exp 01/14
RECALLING FIRM
American Health Packaging, Columbus, OH
REASON FOR RECALL
Subpotent
 
PRODUCT
GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08), and EXACTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 16 fl. oz. (NDC 58552-125-16)
CODE
1 fl. oz. and 8 fl. oz.: Batch/Lot 615688 (exp. 06/2014) and Batch/Lot 617689 (exp. 11/2014); 16 fl. oz: Batch/Lot 615649 (exp. 05/2014).
RECALLING FIRM
Hi-Tech Pharmacal Co., Inc., Amityville, NY
REASON FOR RECALL
Subpotent; phenylephrine HCl

 

  • No pending recalls for the October 16th, 2013 Enforcement Report
  • No pending recalls for the October 9th, 2013 Enforcement Report

 

  • Pending recalls for the October 2nd, 2013 Enforcement Report 

 

PRODUCT
Venlafaxine (Venlafaxine HCl) Extended Release, 225 mg, Rx only, a) 30 count (NDC 0131-3268-32) and b) 90 count (NDC 01310-3268-46) tablets
CODE
Lot #: a) 58975, 58976, 58977, 65165, Exp 1/14; b) 58973, 58974, 65131, Exp 1/14
RECALLING FIRM
Osmotica Pharmaceutical Corp., Marietta, Georgia
REASON FOR RECALL
Failed dissolution specifications – some tablets do not meet the specification for dissolution at the 12 hour time point at 18 months of product shelf life.
 
PRODUCT
a)    Badger SPF 30 Baby Sunscreen Lotion 4 oz
b)    Badger SPF 30 Kids Sunscreen Lotion 4 oz
CODE
a)    Lot #’s 3024A, 3057B, 3063A, 3063B, 3132A, 3133A; UPC: 634084490091& 634084490114
b)    Lot # 3164A; UPC: 634084490145 & 634084490169
RECALLING FIRM
W.S. Badger Company Inc., Gilsum, New Hampshire
REASON FOR RECALL
Microbial contamination of non-sterile products
 
PRODUCT
Next Choice" One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg, NDC 52544-287-54
CODE
Lot Numbers: 580974AA and 580975AA. Expiration Dates: Sep 2014. UPC Codes: Blister Card 3 52544 28754 7. Carton 3 52544 28754 7.
RECALLING FIRM
Watson Laboratories Inc. Corona, CA 92880-1724
REASON FOR RECALL
Failed Tablet/Capsule Specifications: Push through breakage of product in blister packs
 
PRODUCT
Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL), Sterile, OTC, labeled as follows:  (a) equate brand Restore Tears Lubricant Eye Drops, Carboxymethylcellulose Sodium 0.5%, Sterile, 1 FL OZ (30 mL) -- Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716; (b) cvs pharmacy brand LUBRICANT EYE DROPS FOR MILD TO MODERATE DRY EYE, STERILE, 1 FL OZ (30 mL) -- Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895; (c) up & up brand lubricant eye drops for mild to moderate dry eye, STERILE, 1 FL OZ (30 mL) -  Dist. by Target Corp. Mpls., MN 55403.  
CODE
Lot 11440, expiration date 09/2013, labeled for CVS; Lot 11441, expiration date 09/2013, labeled for CVS; Lot 12042, expiration date 01/2014, labeled for Wal-Mart and CVS; Lot 12103, expiration date 02/2015, labeled for Wal-Mart; Lot 12203, expiration date 05/2015, labeled for Wal-Mart and CVS; Lot 12207, expiration date 05/2015, labeled for Wal-Mart; Lot 12293, expiration date 08/2015, labeled for Wal-Mart; Lot 12352, expiration date 09/2015, labeled for Target and CVS; Lot 12356, expiration date 09/2015, labeled for Target and CVS. 
RECALLING FIRM
Altaire Pharmaceuticals, Inc., Aquebogue, NY
REASON FOR RECALL
Non-Sterility: Altaire Pharmaceuticals, Inc. is recalling 9 lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution sold under several brands because the preservative may not be effective through expiry. 
 
  • No pending recalls for the September 25th, 2013 Enforcement Report

 

  • Pending recalls for the September 18th, 2013 Enforcement Report

 

PRODUCT
a)      0.25% Bupivacaine HCl Injection, USP, 2.5mg/mL, 30 mL, Single-dose, NDC 0409-1159-02
b)      0.75% Bupivacaine HCl Injection, USP, 7.5mg/mL, 30 mL, Single-dose, NDC 0409-1165-02
CODE
a)      Lot # 18-136-DK, Exp. 6/14
b)      Lot # 23-338-DK, Exp. 11/14
RECALLING FIRM
Hospira Inc., Lake Forest, Illinois
REASON FOR RECALL
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials
 
PRODUCT
a)            B-50 capsules, 100-count bottle, Healthy Life Chemistry By Purity First, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017
b)            Multi-Mineral capsules, 200-count bottle, Healthy Life Chemistry By Purity First, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017
CODE
a)    B-50 capsules, 100-count bottle, lot #: F03Q, C02R
b)    Multi-Mineral capsules, 200-count bottle, lot #: 12-829
RECALLING FIRM
Healthy Life Chemistry Inc., dba Purity First, Deer Park, NY
REASON FOR RECALL
Marketed Without An Approved NDA/ANDA: FDA and New York State Department of Health analysis found these products to contain steroids or steroid-like substances, making them unapproved new drugs.
 
PRODUCT
a)    Zi Xiu Tang Bee Pollen capsules, 60-count bottles, UPC 6937000700019
b)    Ultimate Formula, 48-count bottles, UPC 793573041401
CODE
a)    Lot numbers 04/15/2012, 05/15/2012, 06/15/2012, and 07/15/2012
b)    Lot numbers 05/25/2012, 07/29/2012, and 08/05/2012
RECALLING FIRM
Zi Xiu Tang Success, LLC, Kutztown, PA
REASON FOR RECALL
Marketed Without An Approved NDA/ANDA: FDA analysis found the products to contain undeclared sibutramine, a previously approved FDA product indicated for weight loss that was removed from the market for safety reasons, making these products unapproved new drugs.

 

  • Pending recalls for the September 11th, 2013 Enforcement Report

 

PRODUCT
Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5-650MG Tablets, Rx only, 500 Count Bottles (NDC 0591-2611-05)
CODE
706224A and 706225A. Exp. 04/15
RECALLING FIRM
Watson Laboratories Inc, Corona, CA
REASON FOR RECALL
Defective Container: Bottles may not have tamper evident seals properly seated
 
PRODUCT
Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML, Rx only, (NDC 43093-104-01) 
CODE
PL520, PL521, PL522 and PL523 Exp. 08/13
RECALLING FIRM
Fusion Pharmaceuticals, LLC, Camarillo, CA
REASON FOR RECALL
Lack of Assurance of Sterility: Total Yeasts and Molds Count (TYMC) for a component within the Dicopanol FusePaq Kit which is outside the acceptance criteria
 
PRODUCT
Cubicin (daptomycin) 50 mg, lyophilized powder, Single-Use Vials, Rx only, NDC 67919-011-01
CODE
Lot Numbers: Lot 950453F, Exp. 12/06/2013 Lot 090203F, Exp. 09/07/2014 Lot 201703F, Exp. 08/31/2015 Lot 201653F, Exp. 09/01/2015
RECALLING FIRM
Cubist Pharmaceuticals, Inc., Lexington, MA
REASON FOR RECALL
Presence of Foreign Substance; glass particulates found in vials
 
PRODUCT
1)    Evil Root Capsules Sexual Enhancement Supplement, 1200 mg, 6 count bottles
2)    72HP Capsules Sexual Enhancement Supplement, 500 mg, 1 count blister pack
3)    Pro PowerMax Sexual Enhancement Supplement, 450 mg, 1 count blister pack
CODE
All Lots and Codes
RECALLING FIRM
Fabscout Entertainment, Fort Lauderdale, FL
REASON FOR RECALL
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products were found to contain an undeclared active pharmaceutical ingredient: SILDENAFIL and/or Tadalafil
 
PRODUCT
5% Lidocaine HCl and 7.5% Dextrose Injection, USP 2mL Single Dose Ampuls, Rx only, NDC 0409-4712-01
CODE
Lot 23-337-DK
RECALLING FIRM
Hospira, Inc., Lake Forest, IL
REASON FOR RECALL
Presence of Particulate Matter; visible particulates observed in glass ampuls
 
  • No pending recall for the September 4th, 2013 Enforcement Report

 

  • Pending recall for the August 28th, 2013 Enforcement Report

 

PRODUCT

Multiple specific unit dose repackaged products
CODE
Multiple codes
RECALLING FIRM
Aidapak Services LLC, Vancouver, Washington
REASON FOR RECALL
Label mix-up: Incorrect label placed on products

 

PRODUCT

a)    Clalis capsules, 50 mg, 6 count bottle, no UPC available
b)    Silver Sword capsules, 180 mg, 16 count clamshell tin, UPC 1 234658 970128  12345
CODE
All lots; no expiration date available
RECALLING FIRM
Fabscout Entertainment Inc., Ft. Lauderdale, FL
REASON FOR RECALL
Marketed without an Approved NDA/ANDA: product found to contain sildenafil
 
  • Pending recalls for the August 21st, 2013 Enforcement Report

 

PRODUCT
Cetacaine Topical Anesthetic Liquid, Rx only, 1) 14 g, (NDC 10223-0202-2); 2) Kit w/14g (NDC 10223-0202-3); 3) 30 g (NDC 10223-0202-4)
CODE
Lot 470 exp. 04/13, 471 exp. 06/13, 472 exp. 10/13
RECALLING FIRM
Cetylite Industries, Inc., Pennsauken, NJ 08110
REASON FOR RECALL
Subpotent Drug: tetracaine is below specification at the 21 month stability test point.
 
 
PRODUCT
Phenytoin Sodium Extended Release Capsules USP, 100 mg, 1000 count bottles, Rx only, NDC 65162-212-11
CODE
Lot HL50611
RECALLING FIRM
Amneal Pharmaceuticals of NY, Hauppauge, NY
REASON FOR RECALL
Failed Dissolution Specifications; 18 month time point
 
  • Pending recall for the August 14th, 2013 Enforcement Report
 
PRODUCT
Mavik Tablets (trandolapril) 4 mg, 100 count bottle, Rx only, NDC 0074-2280-13
CODE
Lot 22033GY, exp. 4/30/2016
RECALLING FIRM
AbbVie, North Chicago, IL
REASON FOR RECALL
Labeling: Incorrect Package Insert
 
  • Pending recalls for the August 7th, 2013 Enforcement Report

 

PRODUCT
Rifadin®, Rifampin capsules, 150 mg 30 capsule bottle, Rx only, NDC 0068-0510-30
CODE
Lot# 3097657, Exp 03/15
RECALLING FIRM
Sanofi US, Bridgewater, NJ
REASON FOR RECALL
Subpotent Drug: low fill was observed in two finished product lots
 
 
PRODUCT
Clobetasol Propionate Cream USP, 0.05%, 15 gm tubes, Rx only, NDC 50383-267-15
CODE
Lot 619442, exp 1/2015
RECALLING FIRM
Hi-Tech Pharmacal Co, Inc., Amityville, NY
REASON FOR RECALL
Labeling: Label Mix up; some cartons labeled as Clobetasol Propionate Cream USP contains tubes labeled as Clobetasol Propionate Gel.  The actual product in the tube is Clobetasol Propiante Cream
 
 
PRODUCT
Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) bottles, Rx only
CODE
1000’s: lots 67328A, 67329A, 67330B, 67330C exp 12/2013; 68061B, 68065A exp 01/2015; 68666A, 68666B, 68667A exp 5/2015, 69721A 12/2015 and 69722 exp 2016
5000’s: lots 68064A exp 01/2015 and 68666A exp 05/2015
RECALLING FIRM
West-ward Pharmaceuticals Corp, Eatontown, NJ
REASON FOR RECALL
Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets
 
  • Pending recalls for the July 31st, 2013 Enforcement Report

 

PRODUCT
DIANEAL Low Calcium PD Solution, Luer, Single Bag (MBU-FLEX II Container) Dextrose 1.5%, Fill Volume 5000mL; Container Size 6000mL.
CODE
Product Code: L5B4826, Lot#C886820, Exp 11/14
RECALLING FIRM
Baxter Healthcare Corp., Deerfield, IL
REASON FOR RECALL
Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.
 
PRODUCT
a)    Volcano Male Enhancement Capsules, 1500 mg, packaged in 1-count capsules per plastic pop to container
b)    Volcano Male Enhancement Liquid, 60 mL bottle, UPC 6 09613 85996 0
CODE
All lots
RECALLING FIRM
Myson Corporation, Inc., Long Beach, CA
REASON FOR RECALL
Marketed Without An Approved NDA/ANDA: products were found to contain undeclared active ingredients making them unapproved new drugs.
 
 
PRODUCT
Propofol Injectable Emulsion 1%, 1g/100mL 100mL Single patient infusion vial, Rx only, NDC 0409-4699-33
CODE
Lot 07-950-DJ Exp. Date 1JUL2013, 10-101-DJ Exp. Date 1OCT2013, and 10-102-DJ Exp. Date 1OCT2013
RECALLING FIRM
Hospira Inc., Lake Forest, IL
REASON FOR RECALL
Presence of Particulate Matter; single visible particulate identified during retain sample
 
 
PRODUCT
1)    DuetDHA Balanced Prescription Prenatal Vitamins, combo pack of 30 tablets and 30 softgel capsules and 5 blister care physician samples (NDC 44118-800-05), Rx only, (NDC 44118-775-30 and NDC 4418-800-30)
2)    DuetDHA 400 Prescription Prenatal Vitamins, 30 day supply – 30 tablets and 30 softgel capsules, Rx only, NDC 44118-807-30 and NDC 76331-807-30
3)    DuetDHA 400ec, Prescription Prenatal Vitamins, 30 day supply – 30 tablets and 30 softgel capsules,  Rx only, NDC 44118-809-30 and NDC 76331-809-30
4)    NataChew Prenatal Multivitamin-Multimineral Tablets, 5 tablet blister card physician sample (NDC 44118-902-05) and 90 count bottle (NDC 44118-902-90), Rx only
5)    DuetDHA 430 Prescription Prenatal Vitamins, 30 day supply combination pack – 30 tablets and 30 softgel capsules, Rx only, NDC 76331-808-30
6)    DuetDHA 430ec Prescription Prenatal Vitamins, 30 day supply – 30 tablets and 30 softgel capsules, Rx only, NDC 76331-810-30
7)    NataKomplete Prenatal Multivitamin-Multimineral Tablets, 5 tablet blister card physician sample (NDC 76331-909-05) and 30 count bottles (76331-909-30)
 
CODE
1)    NDC 44118-775-30; Lot# 12120001 exp 10/14/12120002 exp 10/14, NDC 44118-800-30; Lot 12120001 exp 10/14/12080002 exp. 8/2014 and NDC 44118-800-05; Lot 12120002 exp 10/14/12020001 exp 8/14
2)    40614A, exp 9/14 and 39736A exp 3/14
3)    40614B exp 9/14 and 39736A exp 3/14
4)    41065A exp 9/14 (physician samples);  41065 exp 10/14 and 41099 9/14
5)    39736A exp 3/14 and 41667 exp 12/14
6)    39736A exp 3/14
7)    40186 exp 5/14
RECALLING FIRM
Eckson Labs, Wilmington, DE
REASON FOR RECALL
Subpotent; Vitamin A (beta carotene)
 
  • Pending recalls for the July 24th, 2013 Enforcement Report

     

PRODUCT
Bethel 30 capsules OTC dietary supplement packaged in white plastic bottle with green font
CODE
Lot #: 120514, EXP: 12/2014
RECALLING FIRM
Bethel Nutritional Consulting, Inc, New York, NY
REASON FOR RECALL
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contained undeclared sibutramine and phenolphthalein, two active ingredients that were once marketed in the U.S. but removed due to safety reasons, making this product an unapproved new drug
 
PRODUCT
Methylphenidate Hydrochloride Extended-Release Capsules ,1) 20 mg, 100 count bottle,
(NDC 0093-5346-01), 2) 30 mg  100 count bottle (NDC 0093-5347-01) 3) 40mg 100 count bottle 
(NDC 0093-5348-01)
CODE
1) 34010282A, 34010283A, 34010284A, 34010285A, 34010286A and 34010565A, exp 04/14; 34013199A, 34013200A, 34013201A, 34013202A and 34013203A, exp 10/14
2) 34010290A, 34010291A, 34010292A, exp 04/14, 34011855A, 34011856A,
3) 4011857A, 34011858A, 34013216A, 34013217A, 34013218A, exp 06/14
RECALLING FIRM
Teva Pharmaceuticals USA, Inc., Sellersville, PA
REASON FOR RECALL
Failed Dissolution Specification
 
PRODUCT
Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (NDC 52268-523-02)
CODE
3013002 Exp. 8/14
RECALLING FIRM
Braintree Laboratories Inc., Holbrook, MA
REASON FOR RECALL
Defective container; small micro fracture observed in the 2-Liter bottle at the fill line resulting in a small leak when patient reconstitutes the bulk powder

 

  • No Pending recalls for the July 17th, 2013 Enforcement Report 

 

  • Pending recalls for the July 10th, 2013 Enforcement Report

     

PRODUCT

1) Errin(R) (Norethindrone Tablets, USP), 0.35 mg, Rx only, NDC 0555-0344-58
2) Camila(R) (Norethindrone Tablets, USP), 0.35 mg, Rx only, NDC 0555-0715-58
CODE
1)    Lot numbers 33801773A, exp 7/14; 33801774A, exp 8/14; 33801775A, exp 9/14; 33801776A, exp 9/14; 33802427A, exp 12/14; 33802428A, exp12/14; 33802429A, exp 12/14; 33802430A, exp 12/14; 33802925A, exp 3/15; 33802926A, exp 3/15; 33803383A, exp 6/15; 33803384A, exp 6/15; 33803385A, exp 6/15; 33803387A, exp 6/15; and 33803685A, exp 6/15.
2)    Lot numbers 33802107A, exp 9/13; 33802108A, exp 9/13; 33802109A, exp 10/13; 33802110A, exp 10/13; 33802111A, exp 10/13; 33802112A, exp10/13; and 33802560A, exp 1/14.
RECALLING FIRM
Teva Pharmaceuticals, USA Inc, Sellersville, PA 18960
REASON FOR RECALL
Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
 
PRODUCT
AmBisome (amphotericin B) liposome for injection, For intravenous Infusion Only, Rx only, single use vial
CODE
Lot number/ Expiry Date 042262AD 6/2015; 042262AD1 6/2015; 042263AD 6/2015; 042263AD1 6/2015; 042264AD 6/2015; 042265AD 6/2015: 042265AD1 6/2015; 042265AD2 6/2015 42269AK Assigned by market; 042270AD 7/2015; 042270AD1 7/2015; 042270AD3 7/2015; 042270AD4 7/2015 042273AD 7/2015 & 7/2-16 - Germany only; 042285AD 8/2015 and 8/2016 - UK only; 042293AD Assigned by Market; 042293AE Assigned by Market; 042293AK Assigned by Market; 042298AD 09/2015; 0422A6AD 10/15 for Finland, Greece, Turkey; 10/2016 UK and Lebanon; 0422B0AD 10/2015 for Turkey, Netherland, France; 10/2016 - Poland; 0422B0AD1 10/2015; 042304AD1 - 01/2016; 042311AD 01/2016.
RECALLING FIRM
Gilead Sciences Inc., Foster City, CA
REASON FOR RECALL
Lack of Assurance of Sterility; Some units exhibited media fill failures.
 
PRODUCT
Ethambutol HCl Tablets 400 mg, Rx only, NDC 61748-014-06
CODE
Lot 69968B Exp. 03/14
RECALLING FIRM
West-Ward Pharmaceutical Corp, Eatontown, NJ
REASON FOR RECALL
Out of Specification result for Description and Odor
 
PRODUCT
VIVITROL® (naltrexone for extended-release injectable suspension) 380 mg/vial, Rx only, NDC 65757-303-02
CODE
402-3683AA, EXP 10/13, 2011-003, EXP 08/13
RECALLING FIRM
Alkermes, Inc., Waltham, MA
REASON FOR RECALL
Lack of Assurance of Sterility
 
  • Pending recalls for the July 3rd, 2013 Enforcement Report 
 
PRODUCT
AmBisome (amphotericin B) liposome for injection, 50mg Single Use Vial, Rx, Distributed by Astella Pharma US Inc, Northbrook, IL, Manufactured by Gilead Sciences Inc, San Dimas, CA, NDC 0469-3051-30
CODE
Lot #: 042267AA, Exp 07/2015; 042287AA, 042289AA, 042291AA, Exp 08/2015
RECALLING FIRM
Astellas Pharma US, Inc., Northbrook, IL
REASON FOR RECALL
Lack of Sterility Assurance: During a routine simulation of the manufacturing processes and equipment used for the manufacturing of AmBisome, a bacterial contamination was detected in some of the media fill units
 
PRODUCT
Oxytocin Injection, USP (synthetic), 10 Units/mL, For IN Infusion or IM Use, Rx only, APP Pharmaceuticals, LLC, Schaumburg, IL, NDC 63323-012-01
CODE
Lot 6003648, Exp. 6/30/2013
RECALLING FIRM
Fresenius Kabi USA, LLC, Lake Zurich, IL
REASON FOR RECALL
SubPotent
 
PRODUCT
Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, Rx, NDC 0781-4058-15
CODE
Lot: LF01213A, Exp. 02/14
RECALLING FIRM
Sandoz Incorporated, Broomfield, CO
REASON FOR RECALL
Contraceptive Tablets out of Sequence
 
PRODUCT
Enablex (darifenacin) Extended Release Tablet, Rx 15 mg per tablet, NDC 0078-9420-07
CODE
Lot F1002 - Expiration 12/13
RECALLING FIRM
Warner Chilcott US LLC, Rockaway, NJ 07866
REASON FOR RECALL
Failed Stability Specifications
 
PRODUCT
buPROPion Hydrochloride Extended-Release Tablets, USP, 100 mg, 10 X 10 Unit-Dose Tablets, Rx, NDC 68084-470-11(single dose) NDC 68084-470-01 (carton)
CODE
Lot 114500, Exp. 08/2013
RECALLING FIRM
Amerisource Health Services dba American Health Packaging, Columbus, OH
REASON FOR RECALL
Defective Container; package defect of blister cards caused stability failures at the 9 month timepoint for discolored tablets, dissolution and related compounds assessment
              
PRODUCT
PredniSONE Tablets USP 20 mg, 10 x 10 Unit-Dose Tablets, Rx only, NDC 0054-0018-20
CODE
261739A, Exp 10/2014
RECALLING FIRM
Roxane Laboratories Inc., Columbus, OH
REASON FOR RECALL
Labeling; Missing label; little or no printing on paper backing of blister cards
                                                                    
PRODUCT
Merrem I.V. (meropenem for injection), 1 g/30 mL vial, Rx only, NDC 0310-0321-30
CODE
JX109, exp 2/2015 and JY042, exp 2/2015
RECALLING FIRM
AstraZeneca Pharmaceuticals LP, Wilmington, DC
REASON FOR RECALL
Presence of Precipitate; incomplete constitution upon addition of diluent
 
  • Pending recalls for the June 26th, 2013 Enforcement Report

 

PRODUCT
Enteric Coated Aspirin Tablets, 81 mg, 120-count bottles, NDC 0536-3086-41, UPC 3 0536-3086-41 9, Distributed by: Rugby Laboratories, Inc. Duluth, Georgia 30097
CODE
Lot 13A026, Exp 01/15
RECALLING FIRM
Advance Pharmaceutical Inc., Holtsville, NY
REASON FOR RECALL
Presence of foreign acetaminophen 500 mg tablets in a bottle labeled as enteric coated aspirin 81 mg tablets.
 
  • No pending recalls for the June 19th, 2013 Enforcement Report

 

  • Pending recalls for the June 12th, 2013 Enforcement Report

PRODUCT

VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 (USA); Mfd. by MN Pharmaceuticals; Made in Turkey, NDC 25021-657-10.
CODE
Lot #s: 11I30481A, 1130721A, Exp 09/13; 11I32581A, Exp 10/13
RECALLING FIRM
Sagent Pharmaceuticals Inc., Schaumburg, IL
REASON FOR RECALL
Failed Impurities/Degradation Specifications: A high out of specification impurity result was detected during routine quality testing of stability samples at the 18-month test interval.
 
PRODUCT
Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 92880 USA; Distributed by: Watson Pharma, Inc.
CODE
Lot #: Patch 453658; Carton 453658A, Exp 09/13
RECALLING FIRM
Actavis, Salt Lake City, UT
REASON FOR RECALL
Failed Impurities/Degradation Specifications
 
PRODUCT
Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL (75 mg/5 mL), One Pint (473 mL), Rx only, NDC 0472-0383-16
CODE
Lot Numbers: 247900, exp 6/13; 251000, exp 7/13; 256000, exp 9/13; 261200, exp 10/13; 263600, exp 11/13, 266700, exp 12/13; 277100, exp 3/14; 280300, exp 4/14; and 284300, 5/15
RECALLING FIRM
Actavis South Atlantic LLC, Sunrise, FL
REASON FOR RECALL
Failed Impurity/Degradation Specification; out of specification result for “Related Compound C” at 9 month stability
 
  • Pending recalls for the June 5th, 2013 Enforcement Report

PRODUCT

Nicardipine HCl Injection 2.5 mg/mL, 10 mL vial, Rx only, NDC 0143-9689-10
CODE
PLNJ1201, Exp 4/2014, PLNJ1202, Exp 5/2014
RECALLING FIRM
West-Ward Pharmaceuticals Corp, Eastontown, NJ
REASON FOR RECALL
Failed Impurity/Degradation Specification; NPP-D (9 month stability)
 
PRODUCT
Ondansetron Injection USP 4 mg/2 mL, 2 mL Fliptop Vial, Rx only, NDC 0409-4755-03
CODE
25394DK
RECALLING FIRM
Hospira Inc., Lake Forest, IL
REASON FOR RECALL
Lack of Assurance of Sterility; solution may have come in contact with polyethylene particulate while being processed
 
  • No pending recalls for the May 29th, 2013 Enforcement Report

 

  • Pending recalls for the May 22nd, 2013 Enforcement Report

 

PRODUCT
Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g
CODE
Lot # E112, Exp 05/14) and J062 Exp 09/14
RECALLING FIRM
Mission Pharmacal Co, Boerne Texas
REASON FOR RECALL
Superpotent
 
 
PRODUCT
1)      Levoxyl (levothyroxine sodium) tablets, USP, 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles (NDC 60793-850-10)
2)      Levoxyl (levothyroxine sodium) tablets, USP, 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles (NDC 60793-851-10)
3)      Levoxyl (levothyroxine sodium) tablets, USP, 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles (NDC 60793-852-10)
4)      Levoxyl (levothyroxine sodium) tablets, USP, 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles (NDC 60793-853-10)
5)      Levoxyl (levothyroxine sodium) tablets, USP, 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles (NDC 60793-854-10)
6)      Levoxyl (levothyroxine sodium) tablets, USP, 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles (NDC 60793-855-10)
7)      Levoxyl (levothyroxine sodium) tablets, USP, 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles (NDC 60793-856-10)
8)      Levoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles (NDC 60793-857-10)
9)      Levoxyl (levothyroxine sodium) tablets, USP, 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles (NDC 60793-858-10)
10)   Levoxyl (levothyroxine sodium) tablets, USP, 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles (NDC 60793-859-10)
11)   Levoxyl (levothyroxine sodium) tablets, USP, 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles (NDC 60793-860-10)
CODE
1)      Lot # a) 65228, Exp. 06/13; 65636, Exp. 08/13; b) 65180, Exp. 05/13; 65769, Exp. 07/13
2)      Lot # a) 64934, Exp. 4/13; 65059, Exp. 5/13; 65179, Exp. 4/13; 65630, Exp. 7/13; 65916, Exp. 8/13; 66367, Exp. 10/13; and 66718, Exp. 11/13; b) 64338, Exp. 4/13; 64932, Exp. 4/13; 65060, Exp. 5/13; 65235, Exp. 6/13; 65853, Exp. 6/13; and 65962, Exp. 7/13
3)      Lot # a) 64197, Exp. 4/13; 64339, Exp. 4/13; 65061, Exp. 5/13; 65236, Exp. 6/13; 65917, Exp. 8/13; 66122, Exp. 8/13; and 66427, Exp. 9/13; b) 64340, Exp. 4/13; 64933, Exp. 4/13; 65062, Exp. 5/13; 65237, Exp. 6/13; 65238, Exp. 6/13; and 66121, Exp. 8/13
4)      Lot # a) 64935, Exp. 5/13; 65239, Exp. 6/13; 65900, Exp. 8/13; 66370, Exp. 10/13; and 66391, Exp. 9/13; b) 64927, Exp. 5/13; and 65240, Exp. 6/13
5)      Lot # a) 64341, Exp 04/13;  64928, Exp. 5/13; 65064, Exp. 5/13; 65233, Exp. 7/13; 66162, Exp. 8/13; 66365, Exp. 10/13; and 66677, Exp. 11/13; b) 64342, Exp. 4/13; 64929, Exp. 5/13; 65065, Exp. 5/13; 65234, Exp. 7/13; 65539, Exp. 7/13; 65901, Exp. 8/13; and 66163, Exp. 8/13
6)      Lot # a) 64936, Exp. 5/13; 65634, Exp. 7/13; 66295, Exp. 9/13; 66669, Exp. 11/13; b) 65063, Exp. 5/13 and 65767, Exp. 7/13
7)      Lot # a) 64333, Exp. 5/13; 64937, Exp. 6/13; 65629, Exp. 7/13; and 66296, Exp. 9/13; b) 64931, Exp. 5/13 and 65766, Exp. 7/13
8)      Lot # a) 64190, Exp. 4/13; 64331, Exp. 6/13; 65642, Exp. 7/13; and 66297, Exp. 9/13; b) 64326, Exp. 4/13; 64332, Exp. 6/13; and 65771, Exp. 7/13
9)      Lot # a) 65066, Exp. 5/13 and 65644, Exp. 7/13; b) 64327, Exp. 4/13 and 65772, Exp. 7/13
10)   Lot # a) 64329, Exp. 5/13; 65229, Exp. 6/13; and 65913, Exp. 9/13; b) 64330, Exp. 5/13; 65230, Exp. 6/13; and 65915, Exp. 9/13
11)   Lot # a) 64301, Exp. 4/13 and 65628, Exp. 7/13; b) 64300, Exp. 4/13 and 65765, Exp. 7/13
RECALLING FIRM
King Legacy, a wholly owned subsidiary of Pfizer, Bristol, TN
REASON FOR RECALL
Subpotent
 
PRODUCT
Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial
CODE
Lot No. 503B023, Exp. 08/13; 503B028, 503B029, 503B030, 503B031, 503B032, 503B033, Exp. 11/13; 503C001, 503C002, 503C003, 503C004, Exp. 12/13; 503C009, Exp. 01/14; 503C010, 503C011, 503C012, 503C014, Exp. 02/14; 503C015, 503C016, 503C017, 503C019, 503C020, Exp. 04/14
RECALLING FIRM
Apotex Corp., Weston, FL
REASON FOR RECALL
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
 
PRODUCT
1)      Methotrexate 25 mg/mL Injection, 10 mL vial
2)      Avastin 1.25 mg/mL Injection, 4mL vial
3)      Baclofen 500 mcg/mL Injection, 22 mL vial
4)      Baclofen 1,000 mcg/mL Injection, 20 mL & 40 mL vial
5)      Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injection, 45 mL vial
6)      Betamethasone 6 mg/mL Injection, 5mL vial
7)      Dexpanthenol 200 mg/mL Injection, 100 mL vial
8)      Dexamethasone 10 mg/mL Injection, 2 mL vial
9)      Sodium EDTA 10 mg/mL Injection, 250 mL vial
10) Glutathione 200 mg/mL Injection, 50 mL vial
11) Hydroxyprogesterone 250 mg/mL Injection, 4 mL, 10 mL, 6 mL, & 8mLvial
12) Lipoic Acid 25 mg/mL, 100 mL vial
13) Mitomycin 0.3 mg/mL, 10 mL vial
14) Methylcobalamin 1,000 mcg/mL, 50 mL vial
15) Procaine 1%, 100 mL & 250 mL vial
16) Ascorbic Acid 50 mg/mL 500 mL vial
17) B-Complex 100 mg/mL, 50 mL vial
18) Phosphatidyl Choline 10%, 500 mL vial
19) Mic+b12 25/50/50mg/1000 mcg/mL, 30 mL vial
20) Testosterone Cypionate 200 mg/mL 10 mL vial
21) Morphine Sulfate 25 mg/mL 40 mL vial
22) Carnosine 5% Ophthalmic Drop 5 mL dropper
23) Praziquantel 56.8 mg 50 mL vial
24) Mic 30 mL vial
25) Tr-mix 5 mL & 10 mL
CODE
All lots
RECALLING FIRM
The Compounding Shop, St. Petersburg, FL
REASON FOR RECALL
Lack of assurance of Sterility; Significant CGMP deviations were identified at an FDA inspection associated with the quality control processes that could impact the potential sterility of the products
 
PRODUCT
Methotrexate Sodium USP Injection, 25 mg/mL, 40 mL single dose vial, NDC 66758-041-01
CODE
Lot CL0996 and CJ4948
RECALLING FIRM
Sandoz Incorporated, Broomfield, CO
REASON FOR RECALL
Presence of Particulate Matter
 
  • Pending recalls for the May 15th, 2013 Enforcement Report

 

PRODUCT
Lightning Rod Male Sexual Enhancement Dietary Supplement, 500 mg/capsule, 3 count bottles, UPC 6 89076 20257 2; 12 count bottles, UPC 6 89076 20297 8
CODE
No lot codes on product
RECALLING FIRM
Chang Kwung Products, Woodland Hills, CA
REASON FOR RECALL
Marketed Without An Approved NDA/ANDA: because it contains an undeclared analogue of sildenafil. Sildenafil is an active ingredient used in an FDA-approved product for the treatment of male erectile dysfunction (ED), making it an unapproved new drug.
 
  • No pending recalls for the May 8th, 2013 Enforcement Report

 

  • Pending recalls for the May 1st, 2013 Enforcement Report

 

PRODUCT
1) 3M Brand First Aid Kit, 2) Medi-First Brand First Aid Kit, 3) First Aid Kit (No Brand)
CODE
1) 11215-05,11216-05, 11216-06, 11217-05
2) 11214-07
3) 20-HBC-01015CCREV1
RECALLING FIRM
Total Resources International, City of Industry, CA
REASON FOR RECALL
Firm initiated recall of first aid kits after receiving notice from their vendor for burn cream due to failure in stability testing of the active ingredient Benzalkonium Chloride
 
PRODUCT
Cepacol Sore Throat Lozenges, Cherry 1) 16-count (NDC 63824-711-16), 2) 576-count  (NDC 63824-711-98)
CODE
1) AG156, AG257, AH388, AJ167, AL367, AL555, AL568, AM141
2) AK505, AK570, AH368, AJ000, AG596, AH398
RECALLING FIRM
Reckitt Benckiser Inc., Parsippany, NJ
REASON FOR RECALL
Product did not conform to the 18-month (real time) stability test interval specification for active Free Benzocaine.
 
PRODUCT
1)    Seasonale (Levonorgestrel/Ethinyl Estradiol Tablets) 0.15 mg/0.03 mg, NDC 51385-058-66
2)    Camrese (levonorgestrel/ethinyl estradiol tablets) 0.15 mg/0.03 mg and ethinyl estradiol 0.01 mg, 2x91 count (NDC 0093-3134-82) and 1x91 count (NDC 0093-3134-91)
CODE
1)    Lot numbers 33802330A, exp 6/2013; and 33802464A, exp 6/2013
2)    Lot numbers 33802566A, exp 03/2013; 33802967A, exp 08/2013; 33803529A, exp 10/2013 and 33803609A, exp 11/2013
RECALLING FIRM
Teva Pharmaceuticals, Sellersville, PA
REASON FOR RECALL
Failed Impurity Specification
 
PRODUCT
Acetylcysteine Ophthalmic Solution
Alprostadil In Ns Injection
Atropine Injection
Bacteriostatic Water For Injection Bimix Injection
Buprenorphine Hcl, Veterinary Injection
Cidofovir Oph Solution
Cyclosporine Ophthalmic
Diazepam Injectible
Dexamethasone Pf
Dmso Aqueous Irrigation 50%
Gentamicin Sulfate Irrigation
Hcg Chorionic Gonadotropin
Hydroxyprogesterone Capr. (G.S.)
Methylcobalamin - Pf
Mic With B6 & B12
Nandrolone Decanoate Injectible
Quadmix Injection
Tacrolimus Ophthalmic
Testosterone Cypionate/Testosterone Enanthate Injection
Testosterone Cypionate/Propionate Injection
Testosterone Cypionate Injection
Trimix Injection
Vancomycin Opthalmic P.F.
Verapamil Injection
CODE
All Lots
RECALLING FIRM
Pallimed Solutions Inc, Woburn, MA
REASON FOR RECALL
Presence of Particulate Matter; filaments observed in vials of sterile compounded products
 
PRODUCT
Bucalsep Oral Solution 1 fl oz (30 mL), NDC 58552-103-01
CODE
Lot 611614, exp 9/2013
RECALLING FIRM
Hi-Tech Pharmacal Co, Inc., Amityville, NY
REASON FOR RECALL
Subpotent; cetlpyridinum chloride
 
PRODUCT
Camila 0.35 mg (norethindrone tablets), 28 day regimen, NDC 54868-4814-00
CODE
Lot# 6Z4C, exp 10/13
RECALLING FIRM
Physicians Total Care, Tulsa, OK
REASON FOR RECALL
Failed Impurity Specification; recalled by manufacturer
 
PRODUCT
Infants Gripe Mixture, Each 5 mL contains: Light Magnesium Carbonate BP, 200.0 mg; Sodium Bicarbonate BP, 100.0 mg; Sucrose, 487.5 mg; Alcohol, 0.362 mL; Fennel Oil BP, 0.004 mL; Dill Oil BP, 0.005 mL), 120 mL bottle, Manufactured by: P.A. Benjamin Manufacturing Co. Ltd., 97 East Street, Kingston, JAMAICA.
CODE
Lot JZ28, Exp 03/13
RECALLING FIRM
Carib Import & Export, Inc., Miami, FL
REASON FOR RECALL
CGMP Deviations
 
PRODUCT
0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09
CODE
Lot 25-037-JT, Exp 1JAN2015
RECALLING FIRM
Hospira Inc., Lake Forest, IL
REASON FOR RECALL
Presence of Particulate Matter: brass particulates were identified in the primary container in the form of several small grey/brown particles.
 
PRODUCT
Walgreen’s Regular Strength Antacid Liquid (Anti-Gas); Mint, packing size 12oz (NDC 0363-0073-02) and 26 oz (NDC 0362-0073-26)
CODE
Lot # 13B0023 *Split lot*; Exp. 02/15
FP-4809 (12 oz.)
FP-4810 (26 oz.)
RECALLING FIRM
Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals
16311 NW 52nd Ave
Miami Gardens, Florida 33014-6209
REASON FOR RECALL
Microbial contamination of non-sterile product: elevated microbial count outside of specifications and possible contamination
 
PRODUCT
Plavix 75mg, 30ct bottle, NDC 054868-4070-00
CODE
Lot # 67JV; Exp. 08/13
RECALLING FIRM
Physicians Total Care, Inc.*Repackager*
12515 E 55th St Suite 100
Tulsa Oklahoma 74146-6234
REASON FOR RECALL
Chemical contamination: Uncharacteristic moldy odor
 
PRODUCT
Donnatal Extendtabs 0.3888mg/46.8mg, 100ct bottle, NDC 66213-0421-10
CODE
Lot # 68864; Exp. 04/13
RECALLING FIRM
West-Ward Pharmaceuticals Corp
200/401/435/465 Industrial Way West
Eatontown, NJ 07724
REASON FOR RECALL
Labeling: Incorrect expiration date
 
  • Pending recalls for the April 24th, 2013 Enforcement Report
PRODUCT
a) Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl) tablets, 20-count tablets per carton
b) Pentrexcilina Jarabe NF (dextromethorphan HBr and guaifenesin) liquid, 118 mL/ 4 fl oz bottle
CODE
a)    Lot # 11611B0, Exp 10/14
b)    Lot # 11649A0, Exp 12/13
 
RECALLING FIRM
OPMX, LLC, San Diego, CA
REASON FOR RECALL
Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.
 
PRODUCT
All Sterile Drug Products in all strengths and presentations compounded, repackaged, and distributed by Green Valley Drugs
CODE
All lots manufactured and distributed between 12/01/12 to 04/08/13.
RECALLING FIRM
FVS Holdings, Inc. dba Green Valley Drugs, Henderson, NV
REASON FOR RECALL
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
 
PRODUCT
Amoxicillin Capsules USP 500 mg, Rx only, 1) 30 count bottle, (NDC 0781-2613-31) 2) 500 count bottle (NDC 0781-2613-05)
CODE
CK2003, CK2004 exp. 04/15, CR4110, CR4111, CS2983, CS2986, CS2988, CS2989, CS2990, CS2991, CS2992, CS2993, CS2994 exp. 07/15, CK3616, CK3617 exp. 04/15
RECALLING FIRM
Sandoz Incorporated, Broomfield, CO
REASON FOR RECALL
Presence of Foreign Substance; due to potential contamination with fragments of stainless steel wire mesh.
 
  • Pending recall for the April 17th, 2013 Enforcement Report

PRODUCT

ROCK-IT MAN capsules, male sexual stimulant, packaged in 1-count (UPC 8 53447 02003 8) and 2-count (UPC 8 53447 00204 1) blister cards, Distributed by Consumer Concepts.
CODE
All lots sold between October 2012 and April 2013
RECALLING FIRM
Consumer Concepts, Inc., Roscoe, IL
REASON FOR RECALL
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain hydroxythiohomosildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug.
 
  • Pending recalls for the April 10th, 2013 Enforcement Report
PRODUCT
  1. Qvar Inhalers (beclomethasone Dipropionate HFA) 40 mcg, 8.7g/120 metered inhalations, Rx only, NDC 59310-202-40
  2. Qvar Inhalers (beclomethasone Dipropionate HFA) 80 mcg, 8.7g/120 metered inhalations, Rx only, NDC 59310-204-80
 
CODE
  1. GNF013A, exp 6/2014, GNF069A, exp 6/2014 & GNG086A, exp 7/2014
  2. GNF014A, exp 6/2014, GNF070A, exp 6/2014 & GNG087A, exp 7/2014
 
RECALLING FIRM
Teva Pharmaceuticals USA, Inc., Sellersville, PA
 
REASON FOR RECALL
Labeling: Not Elsewhere Classified; canister is missing NDC barcode
 
  • Pending recalls for the April 3rd, 2013 Enforcement Report

PRODUCT

Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepally - 500 090 India; NDC 55111-180-15.
CODE
Lot #: C208625, C208984, C209113, C209369, Exp 09/15; and C209680, Exp 10/15.
RECALLING FIRM
Dr. Reddy’s Laboratories, Bridgewater, NJ
REASON FOR RECALL
Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details. 
 
PRODUCT
Cefdinir for Oral Suspension, 125 mg/5 mL, packaged in a) 60 mL bottle (NDC 0093-4136-64); b) 100 mL bottle (NDC 0093-4136-73), Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960.
CODE
a) Lot #: 30304253A, Exp 12/13; b) Lot #: 30304144A, Exp 12/13 and 30304477A, Exp 03/14
RECALLING FIRM
Teva Pharmaceuticals USA, Inc., Sellersville, PA
REASON FOR RECALL
Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.
 
PRODUCT
Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0.
CODE
Lot# 503B019, 503B020, 503B021, Exp 07/13; 503B025, 503B026, 503B027, Exp 09/13; 503C008, Exp 01/14.
RECALLING FIRM
Apotex Corporation, Weston, FL
REASON FOR RECALL
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
 
PRODUCT
Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, NDC 0409-3815-12
CODE
Lot 15-065-DK, Exp 1SEP2013
RECALLING FIRM
HOSPIRA, INC, LAKE FOREST, IL 60045
REASON FOR RECALL
Defective Container: Loose crimp applied to the fliptop vial.
 
  • Pending recalls for the March 27th, 2013 Enforcement Report

PRODUCT

Night Bullet Capsules, 1 count blister, UPC 018505122233
CODE
Lot B43N032
RECALLING FIRM
Green Planet, Inc., Riverside, CA
REASON FOR RECALL
Marketed without an Approved NDA/ANDA; product found to contain sulfohydroxyhomosildenafil and aminotadalafil which are analogues of two FDA approved active ingredients used for the treatment of erectile dysfunction, making it an approved new drug
 
PRODUCT
Torisel Kit (temsirolimus) Injection, 25 mg/mL, Rx, 1 vial Torisel and 1 vial Diluent, NDC 0008-1179-01
CODE
Lots P00025A and P00027B
RECALLING FIRM
Pfizer Inc, New York, New York
REASON FOR RECALL
Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent
 
PRODUCT
Tetracycline HCL Capsules USP 250 mg
CODE
69MO EXP 05/31/2013, 69SH EXP 05/31/2013, 5KXZ EXP 05/31/2012, 5RE1 EXP 05/31/2012
RECALLING FIRM
Physicians Total Care, Inc., Tulsa OK
REASON FOR RECALL
Presence of Particulate Matter; sub-recall from the manufacturers initiated recall due to the potential for particulate matter in the Active Pharmaceutical Ingredient (API).
 
  • Pending recalls for the March 20th, 2013 Enforcement Report

PRODUCT

METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL (NDC 0409-7811-24)
CODE
12-074-JT
RECALLING FIRM
Hospira Inc., Lake Forest, IL
REASON FOR RECALL
Lack of Assurance of Sterility; there is the potential for the solution to leak from the administrative port to the fill tube seal.
 
  • Pending recalls for the March 13th, 2013 Enforcement Report

PRODUCT

METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL (NDC 0409-7811-24)
CODE
12-074-JT
RECALLING FIRM
Hospira Inc., Lake Forest, IL
REASON FOR RECALL
Lack of Assurance of Sterility; there is the potential for the solution to leak from the administrative port to the fill tube seal.
 
PRODUCT
0.9% Sodium Chloride Injection USP, 100 mL (NDC 0409-7984-23)
CODE
05-201-JT
RECALLING FIRM
Hospira Inc., Lake Forest, IL
REASON FOR RECALL
Particulate Matter
 
  • Pending recalls for the March 13th, 2013 Enforcement Report
PRODUCT
Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single use PRE-FILLED syringes and 33 Alcohol Preps (swabs) per box, NDC 68546-317-30
CODE
Lot P53847, Exp 01/14
RECALLING FIRM
Teva Pharmaceuticals USA, Inc., Sellersville, PA
REASON FOR RECALL
Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system.
 
  • Pending recalls for the March 6th, 2013 Enforcement Report
PRODUCT
Hextend 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, (NDC 0409-1555-54)
CODE
10-199-JT
RECALLING FIRM
Hospira Inc., Lake Forest, IL
REASON FOR RECALL
Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag
 
PRODUCT
0.9% Sodium Chloride Injection USP, 100 mL (NDC 0409-7984-23)
CODE
02-117-JT
RECALLING FIRM
Hospira Inc., Lake Forest, IL
REASON FOR RECALL
Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag
 
PRODUCT
Clonazepam Orally Disintegrating Tablets, USP, 0.5 mg CIV, (NDC #0555-0096-96)
CODE
32900136A, Exp. 05/2014
RECALLING FIRM
Teva Pharmaceuticals USA, Inc
REASON FOR RECALL
Failed Content Uniformity Specification
 
  • Pending recalls for the February 27th, 2013 Enforcement Report
PRODUCT
Equate, non-Drowsy Daytime Cold/Flu LiqGel Cap, 20 count Blister pack (NDC 49035-215-60)
CODE
Lot 2AE1549, Exp 02/13
RECALLING FIRM
L. Perrigo Co., Allergan, MI
REASON FOR RECALL
Subpotent; Phenylephrine HCL
 
PRODUCT
Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per bottle (NDC 68462-392-30) and b) 90-count tablets per bottle (NDC 68462-392-90)
CODE
02122956, 02123226, 02123269, 02123480, 02123481, 02122933, 02122955, 02123062, 02123075, 02123085, 02123114, 02123115, 02123124, 02123125, 02123189, 02123199, 02123205, 02123219, 02123253, 02123270, 02123289, 02123295, 02123320, 02123333, 02123343, 02123349, 02123411, 02123421, 02123431, Exp 09/14 and 10/14
RECALLING FIRM
Glenmark Generics Inc., USA; Mahwah, NJ
REASON FOR RECALL
Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an off-odor, described as moldy, musty or fishy in nature which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA).

 

 

PRODUCT
Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop vials, Rx ONLY,  NDC 0409-6102-04
CODE
18-099-DK, Exp 1DEC2013
RECALLING FIRM
Hospira, Inc., Rocky Mount, NC
REASON FOR RECALL
Lack of Assurance of Sterility; possible loose crimp on fliptop vial
 
PRODUCT
Calcium Gluconate Inejction USP, 10% (100 mg/mL), 10 mL Single Dose Vial, Rx only, NDC 63323-311-10
CODE
Lot 6004889, Exp 10/2014
RECALLING FIRM
Fresenius Kabi USA LLC, Schaumburg, IL
REASON FOR RECALL
Labeling: Missing Labels; unlabeled vials in trays
 
PRODUCT
Bupropion Hydrochloride Extended Release Tablets (XL), 300 mg, 30 count bottles, Rx Only, NDC 67767-142-30
CODE
Lot CB1D05A, Exp Jan 2013
RECALLING FIRM
Actavis Pharmaceuticals, Morristown, NJ
REASON FOR RECALL
Failed Dissolutions Specifications; 18 month stability test point
 
PRODUCT
Zarah Drospirenone/Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg; 38 count dialpak, Rx only, NDC 52544-981-28
CODE
Lot #s: 401536AA/401536A; 401537AA/401537/A; 401538AA/401538/A; 406985AA/406985A; 432058AA/432058A; 512685AA/512685A
RECALLING FIRM
Watson Laboratories, Inc., Corona, CA
REASON FOR RECALL
Failed Tablet Specifications; tablets are breaking when pushed through blister pack

 

 

  • Pending recalls for the February 20th, 2013 Enforcement Report

 

PRODUCT
Meprobamate 200 mg Tablets Rx only, 100 count bottle (NDC 0591-5239-01) &
Meprobamate 400 mg Tablets Rx only, 100 count bottle (NDC 0591-5238-01)
CODE
200 mg; Lot 386585A, Exp. 02/13; 429104A, Exp. 06/13; 474487A, Exp. 11/13; 491671A, Exp. Date 01/14.
400 mg; Lot 387879A, Exp. 02/13; 429105A, Exp. 06/13; 474488A, Exp. 11/13; 491672A, Exp. 01/14; 529095A, Exp. 04/14
RECALLING FIRM/MANUFACTURER
Recalling Firm: Watson Laboratories Inc, Corona, CA
Manufacturer: Watson Laboratories Inc, Corona, CA
REASON FOR RECALL
Failed Impurities/Degradation Specifications: Is being recalled because an out of specification result for an unknown impurity.
 
PRODUCT
TEV-TROPIN (somatropin for injection) 5 mg (15 IU), Rx Only (NDC# 57844-336-85)
CODE
LOT #201131320087, Exp Date 09/15
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ferring Pharmaceuticals Inc, Parsippany, NJ
Manufacturer: Antares Pharma, Inc, Minneapolis, MN
REASON FOR RECALL
Some units of Lot 201131320087 are packaged in cartons labeled for Needle-Free Head B but contain Needle-Free Head A kits.
 
PRODUCT
Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible container, NDC 0409-7929-09
CODE
Lot #: 05-019-JT*, Exp 05/01/13; lot number * may be followed by 01, 90, or 91.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL
Manufacturer: Hospira, Inc., Austin, TX
REASON FOR RECALL
Non-Sterility: Confirmed customer complaint where a spore-like structured particulate, consistent with mold, was noted in the solution.
 
PRODUCT
Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible container, NDC 0409-7929-09
CODE
Lot #: 12-160-JT, Exp 12/01/13; lot number * may be followed by 01, or 90.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL
Manufacturer: Hospira, Inc., Austin, TX
REASON FOR RECALL
Non-Sterility: Confirmed customer complaint where a spore-like structured particulate, consistent with mold, was noted in the solution.
 
  • Pending recalls for the February 13th, 2013 Enforcement Report

 

PRODUCT
Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expoectorant, 24 caplet bottles
CODE
24 Coated Caplets, UPC 300240537879, lot numbers NAA0B3T, NAA0BDB, NAA0B3P, NAA0B3R, NAA0B3N, NAA070E, NAA070F, NAA03PX, NAA03B5, NAA03B6
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bayer Healthcare, LLC Morristown, NJ
Manufacturer: Bayer Healthcare LLC, Consumer Care Division, Myerstown, PA
REASON FOR RECALL
Labeling; Label lacks warning; Certain information was inadvertently excluded from the product carton label. The following warning information was excluded: Stop use and ask a doctor if: - Your asthma is getting worse (see Asthma Alert; - You have difficulty sleeping; - You have a rapid heartbeat; - You have tremors, nervousness, or seizure

 

PRODUCT
Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, NDC 0143-1250-01
CODE
Lot 69001A
RECALLING FIRM/MANUFACTURER
Recalling Firm: West-ward Pharmaceutical Corp, Eatontown, NJ 07724
Manufacturer: West-ward Pharmaceutical Corp, Eatontown, NJ 07724
REASON FOR RECALL
Subpotent: Out of Specification results for assay
 
 
PRODUCT
Carisoprodol 350 mg tablets, Rx Only, 100 tablets per bottle, NDC 0143-1176-01
CODE
Lot 69160A
RECALLING FIRM/MANUFACTURER
Recalling Firm: West-ward Pharmaceutical Corp, Eatontown, NJ 07724
Manufacturer: West-ward Pharmaceutical Corp, Eatontown, NJ 07724
REASON FOR RECALL
Mis-labeling: missing the “C-IV” on the labels as per DEA guidance
 
PRODUCT
Crest Pro-Health Invigorating Clean Rinse, 250 mL (NDC 37000-452-02)
CODE 
22155395UA Expires: 07/2014
RECALLING FIRM/MANUFACTURER
Recalling Firm: Procter & Gamble Hair Care Llc, Iowa City, IA
Manufacturer: Procter & Gamble Hair Care Llc, Iowa City, IA
REASON FOR RECALL
Presence of Particulate Matter
 
 
PRODUCT
Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial; UPC 3 61958 01011 5; NDC 61958-0101-1.
CODE
Lot #: B120217A, Exp 05/15
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gilead Sciences, Inc., Foster City, CA
Manufacturer: AAI Pharma Services Corp., Charleston, SC
REASON FOR RECALL
Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).
 
 
PRODUCT
Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065 mg) with Phenobarbital (USP 16.2 mg) Tablets, packaged in a) 1000-count tablets per bottle (NDC 0143-1140-10; b) 5000-count tablets per bottle (NDC 143-1140-51)
CODE
Lot #: 69099A, 69099B, Exp 08/15
RECALLING FIRM/MANUFACTURER
Recalling Firm: West-ward Pharmaceutical Corp., Eatontown, NJ
Manufacturer: West-ward Pharmaceutical Corp., Eatontown, NJ
REASON FOR RECALL
Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.

 

 

  • Pending recalls for the February 6th, 2013 Enforcement Report.

 

PRODUCT
PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension & PULMICORT RESPULES 0.5 mg/2 ml Budesonide Inhalation Suspension
CODE
AH0054 Exp 5/2014; AK0125 Exp 7/2014 & YP0035 Exp 11/2013; YP0140 Exp 12-2013; YP0136 Exp 12/2013; AB0077 Exp 2/2014; AH0133 Exp 5/2014
RECALLING FIRM/MANUFACTURER
Recalling Firm: AstraZeneca LP, Westborough, MA
Manufacturer: AstraZeneca LP, Westborough, MA
REASON FOR RECALL
Budesonide may be above or below the specification range

 

PRODUCT
VERSAPHARM Ethambutol Tablets Rx Only USP 400 mg, a)60 tablets, b)90 tablets, c)100 tablets, d)1000 tablets
CODE
69877A; 68977B; 68978B; 6978C; 68979A - exp JUL 2015 68977C; 68978A exp JUL 2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: West-ward Pharmaceutical Corp., Eatontown, NJ
Manufacturer: West-ward Pharmaceutical Corp., Eatontown, NJ
REASON FOR RECALL
Ethambutol Tablets USP 400 mg have tablets cores that may be discolored
 
PRODUCT
Mitosol (mitomycin for solution) 0.2 mg/vial Kit for Ophthalmic Use, NDC 49771-002-01
CODE
Lot MO98260, Exp 08/2013 and Lot MO86920, Exp 08/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mobius Therapeutics LLC, St. Louis, MO
Manufacturer: Mobius Therapuetics LLC, St. Louis, MO
REASON FOR RECALL
Non Sterile; one or more parts in the kit have been found to contain a strain of yeast identified as Rhodotorula-bacarum

 

PRODUCT
Isoniazid Tablets, USP, 300 mg, 30 tablet bottles, Rx only, NDC 61748-013-30 and 100 tablet bottles NDC 61748-013-01
CODE
Lot 67079A, 67079B and Lot 67079C
RECALLING FIRM/MANUFACTURER
Recalling Firm: West-ward Pharmaceuticals Corp, Eatontown, NJ
Manufacturer: West-ward Pharmaceutical Corp, Eatontown, NJ
REASON FOR RECALL
Failed Dissolution Specifications; 36 month timepoint
 
PRODUCT
Super Power capsules, Proprietary Blend 570 mg, packaged in 2-count capsules per blister pack, Distributed by: Freedom Trading NJ 08863, UPC 7 18122 90678 9
CODE
Lot L08108, Exp 06/15
RECALLING FIRM/MANUFACTURING FIRM
Recalling/Manuafacturing Firm: D&S Herbals, LLC, Woodbridge, NJ
REASON FOR RECALL
Marketed Without An Approved NDA/ANDA: Product was found to contain trace amounts of sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making Super Power an unapproved new drug.
 
  • No pending recalls for the January 30th, 2013 Enforcement Report.
  • Pending recall for the January 23rd, 2013 Enforcement Report.

PRODUCT

Femtrace (estradiol acetate) Tablets 0.9 mg, 100 count bottles, Rx, NDC 0430 0390 24
Femtrace (estradiol acetate) Tablets 0.45 mg, 100 count bottles, Rx, NDC 0430 0389 24
 
CODE
Lot 512348A, exp 01-31-2014
Lot 505969A, exp 02-28-2013

 

RECALLING FIRM/MANUFACTURER

Recalling Firm: Warner Chilcott Company LLC, Fajardo, PR
Manufacturer: Pharmaceutics International, Hunt Valley, MD
 
REASON FOR RECALL
Superpotent; due to excess moisture ingress in individual bottles
 
  • Pending recalls for the January 16th, 2013 Enforcement Report. 

PRODUCT

SLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19685 Varda Ave., Buena Park, CA.
 
CODE
There are no manufacturing codes associated with the product.
 
RECALLING FIRM/MANUFACTURER
Recalling Firm: P & J Trading Co., Fullerton, CA
Manufacturer: unknown

REASON FOR RECALL

Marketed Without an Approved NDA/ANDA: All lots of the dietary supplement Slimdia Revolution are being recalled because they contain sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.
 
  • Pending recalls for the January 9th, 2013 Enforcement Report.

PRODUCT

Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 blistered tablets per carton, Rx only; Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, Pkg by & Distributed by UDL Laboratories, Inc., Rockford, IL 61103; NDC 51079-254-21.

CODE

Lot #: 3037841, 3040859, 3042573, Exp 12/13

RECALLING FIRM/MANUFACTURER

Recalling Firm: Mylan Institutional, Inc. (d.b.a. UDL Laboratories), Rockford, IL
Manufacturer: Qualitest Pharmaceuticals, Charlotte, NC

REASON FOR RECALL

Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.

 

PRODUCT

Zicam Extreme Congestion Relief nasal gel, 0.5 oz. spray bottle, NDC number 62750-005-10.

CODE

Lot #2J23, Exp 09/15

RECALLING FIRM/MANUFACTURER

Recalling Firm: Matrixx Initiatives Inc., Scottsdale, AZ
Manufacturer: BioZone Laboratories Inc., Pittsburg, CA

REASON FOR RECALL

Microbial Contamination of Non-Sterile Products: Firm found Burkholderia cepacia in a single sample of the product taken from the affected lot.

 

PRODUCT

Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only, NDC 0245-0085-11

CODE

RECALLING FIRM/MANUFACTURER

Recalling Firm: Upsher, Smith laboratories, Inc Minneapolis MN 55447
Manufacturer: Catalent Pharma Solutions LLC, Winchester, KY

REASON FOR RECALL

Failed Dissolution Test Requirements

 

PRODUCT

Prednisone Tablets, 10mg, Rx Only, a) 21-count cartons, NDC 45802-303-21 and b) 48-count cartons NDC 45802-303-67.

CODE

  1. 2CV0627, Exp 11/13 and 2DV1239, Exp 10/13, UPC #: 345802303219
  2. 2CV0623, 2CV0625, Exp 11/13; 2DV1238, Exp 10/13, UPC #:345802303677

RECALLING FIRM/MANUFACTURER

Recalling Firm: L. Perrigo Co., 515 Eastern Ave, Allegan, Michigan, 49010-9070
Manufacturer:West-ward Pharmaceutical Corp., 465 Industrial Way W, Eatontown, New Jersey, 07724-2209

REASON FOR RECALL

Presence of Foreign Substance; Tablets contaminated with trace amounts of food-grade lubricant.

 

PRODUCT

Perindopril Erbumine Tablets, 8mg, 100-count bottle, Rx Only, NDC 0054-0112-25.

CODE

Lot #160017A, Exp 04/13

RECALLING FIRM/MANUFACTURER

Recalling Firm: Boehringer Ingelheim Roxane Inc., Columbus, OH, 43216.

Manufacturer: Boehringer Ingelheim Roxane Inc., Columbus, OH, 43216.

REASON FOR RECALL

Impurities/Degradation Products; 18 month stability timepoint

 

PRODUCT

Abilify (aripiprazole) Tablets, 30 mg, Blister Pack of 100 tablets, Rx, NDC 59148-011-35

CODE

2E69023A, Exp. FEB 28 2015

RECALLING FIRM/MANUFACTURER

Recalling Firm: Bristol Myers Squibb Manufacturing Company, Humacao, Puerto Rico
Manufacturer: Bristol Myers Squibb Manufacturing Company, Humacao, Puerto Rico

REASON FOR RECALL

Failed Tablet Hardness

 

PRODUCT

Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 TABLETS

CODE

Lot 12G468, Exp. 07/14

RECALLING FIRM/MANUFACTURER

Recalling Firm: Advance Pharmaceutical Inc., Holtsville NY 11742
Manufacturer: Advance Pharmaceutical Inc., Holtsville NY 11742

REASON FOR RECALL

Adulterated Presence of Foreign Tablets: Firm received complaints that bottles of Ferrous Sulfate 5 gr (325 mg) tablets, 100 ct., an iron supplement, actually contained Meclizine HCl 25 mg tablets, 100 ct., an OTC motion sickness drug.

 

PRODUCT

ESTEE LAUDER DayWear Advanced Multi-Protection Anti-Oxidant Sheer Tint Release Moisturizer Broad Spectrum SPF15, 1.7 FL. OZ. LIQ/50 ml

CODE

A70, A80, AA0, B11, A31, A51, B51, A81, A91, A12, A22, A72, BA0, AB0, BB0, CB0, AC0, BC0, A11, A21, B21, B31, A41

RECALLING FIRM/MANUFACTURER

Recalling Firm: Estee Lauder Inc, New York, NY 10153
Manufacturer: Estee Lauder Inc (Len Ron Mfg), Melville, NY 11747

REASON FOR RECALL

Product Lacks Stability: the active sunscreen ingredient, avobenzone 3%, may not be stable over the shelf life and therefore, the sunscreen effectiveness may be less than labeled.
 
  • No pending recalls for the January 02, 2013 Enforcement Report.
  • No pending recalls for the December 26th, 2012 Enforcement Report.
  • No pending recalls for the December 19th, 2012 Enforcement Report.

 

  • Pending recalls for the December 12th, 2012 Enforcement Report:

PRODUCT

Hydrocodone bitartrate and acetaminophen tablets, USP 10 mg/500 mg, Rx only, 30-count, NDC 0603-3888-16; 60-count, NDC 0603-3888-20; 90-count, NDC 0603-3888-02; 100-count, NDC 0603-3888-21; 120-count, NDC 0603-3888-22; 150-count, NDC 0603-3888-26; 180-count, NDC 0603-3888-04; 500-count, NDC 0603-3888-28; and 1000-count bottles, NDC 0603-3888-32.

CODE

All lots beginning with “C” (total of 101 lots), Exp 12/13

RECALLING FIRM/MANUFACTURER

Recalling Firm: Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL
Manufacturer: Qualitest Pharmaceuticals, Charlotte, NC

REASON FOR RECALL

Superpotent (Multiple Ingredient) Drug: Complaint received for oversized tablets which could be superpotent.

 

  • Pending recalls for the December 5th, 2012 Enforcement Report:

PRODUCT

Cymevene 500 mg Powder for Infusion, For i.v. Infusion only, 5 vials per carton

CODE

Bulk Lot N0019, Exp 11/2014

RECALLING FIRM/MANUFACTURER

Recalling Firm: F. Hoffman-LaRoche Ltd, Basel Switzerland

Manufacturer: JHP Pharmaceuticals, LLC, Rochester, MI

REASON FOR RECALL

Lack of Assurance of Sterility; cracks or breaks around vial lid may compromise sterility

 

  • No pending recalls for the November 28th, 2012 Enforcement Report.
  • No pending recalls for the November 21st, 2012 Enforcement Report.

 

  • Pending recalls for the November 17th, 2012 Enforcement Report:

PRODUCT

Pradaxa Capsules (dabigatran etexilate mesylate) 75mg

CODE

Lot 201900, Exp Jan 2015, NDC 0597 014954

RECALLING FIRM/MANUFACTURER

Recalling Firm: Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT

Manufacturer: Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT

REASON FOR RECALL

Defective container; damaged bottle could allow moisture to get into the bottle and impact the quality of the product

 

  • No pending recalls to report for the November 7th, 2012 Enforcement Report.

 

  • Pending recalls for the October 31st, 2012 Enforcement Report:

PRODUCT

Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple dose vial Bacteriostatic Water for Injection, USP (1.1% benzyl alcohol), Manufactured by Hospira, Inc., for Genentech, Inc., San Francisco, CA 94080-4990, NDC 50242-903-69; and 1 Reconstitution Instructions per kit; Investigation Use only, Genentech, Inc., 1 DNA Way, San Francisco, CA 94080-4990.

CODE

Lot #: 454138, Exp 07/14 (containing Trastuzumab Lot #:886618, Exp 12/14; and Bacteriostatic Water for Injection, USP Lot #: 08-368-DK-01, Exp 07/14)

RECALLING FIRM/MANUFACTURER

Recalling Firm: Genentech Inc., South San Francisco, CA

Manufacturer: Hospira Inc., Rocky Mount, NC

REASON FOR RECALL

Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab for Investigational Use has the potential to contain glass particulates.

 

  • Pending recalls for the October 24th, 2012 Enforcement Report:

PRODUCT

Perphenazine Tablets, USP, 8 mg, 100-count tablets per bottle, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-5092-21

CODE

Lot C1130511A, Exp 5/13

RECALLING FIRM/MANUFACTURER

Recalling Firm: Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville,  AL

Manufacturer: Qualitest Pharmaceuticals Charlotte, NC

REASON FOR RECALL

Tablet Separation: Possibility of cracked or split coating on the tablets

 

PRODUCT

1) Methylprednisolone Acetate (PF) 80 mg/mL Injection, supplied in 1, 2 and 5 mL vials

2) Methylprednisolone Acetate (PF) 40 mg/mL Injection, supplied in 1, 2 and 5 mL vials

3) Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials

4) Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials

CODE

All lot codes

RECALLING FIRM/MANUFACTURER

Recalling Firm: New England Compounding Center, Framingham, MA

Manufacturer: New England Compounding Center, Framingham, MA

REASON FOR RECALL

Non Sterility

 

  • No pending recalls to report for the October 17th, 2012 Enforcement Report
  • No pending recalls to report for the October 10th, 2012 Enforcement Report
  • No pending recalls to report for the October 3rd, 2012 Enforcement Report
  • No pending recalls to report for the September 26th, 2012 Enforcement Report
  • No pending recalls to report for the September 19th, 2012 Enforcement Report.

 

  • Pending recalls for the September 12th, 2012 Enforcement Report:

PRODUCT

BiCNU (carmustine) for injection kit, 100 mg and diluent, kit (NDC 0015-3012-60) contains a vial containing 100 mg carmustine (NDC 0015-3012-18) and an ampule containing 3 mL sterile diluent

CODE

Kit/Vial Lot #: (9L7003A/1803607), Exp 11/12; (9H4209A/1803608), Exp 01/13; (9H4211A/1843251), Exp 02/13; (0B7004A/1843251), Exp 04/13; (0B7005A/2011804), (0E7004A/2011804), Exp 05/13; (0E7006A/2055384), Exp 09/13; (0J7007A/2064024), (1A7005A/2064024), Exp 01/14; (1C7006A/2106210), Exp 04/14

RECALLING FIRM/MANUFACTURER

Recalling Firm: Bristol-Myers Squibb Company, New Brunswick, NJ
Manufacturer: Ben Venue Laboratories Inc., Bedford, OH

REASON FOR RECALL

Superpotent (Single Ingredient) Drug: Overfilled Carmustine vials

 

PRODUCT

Hydromorphone HCl Injection, 2 mg/mL, USP, 1 mL fill in 2.5mL Carpuject, packaged 10 cartridges/carton, NDC 0409-1312-30

CODE

Lot 12720LL, Exp 12/01/13

RECALLING FIRM/MANUFACTURER

Recalling Firm: Hospira Inc., Lake Forest, IL
Manufacturer: Hospira Inc., McPherson, KS

REASON FOR RECALL

Superpotent (Single Ingredient) Drug: overfilled syringe
 

PRODUCT

Hydrocodone bitartrate and acetaminophen tablets, USP, 10/500 mg, 100-count bottles, NDC 0603-3888-21

CODE

Lot C1440512A, Exp 12/13

RECALLING FIRM/MANUFACTURER

Recalling Firm: Qualitest Pharmaceuticals, Huntsville, AL
Manufacturer: Vintage Pharmaceuticals (dba Qualitest Pharmaceuticals), Charlotte, NC

REASON FOR RECALL

Superpotent (Multiple Ingredient) Drug: hydrocodone bitartrate and acetaminophen.

 

PRODUCT

Atrovent HFA (ipratropium bromide) Inhalation Aerosol, 12.9 grams, 200 metered actuations, NDC 68258-8952-01

CODE

Lot F22311, Exp 10/13 and F23989, Exp 11/13

RECALLING FIRM/MANUFACTURER

Recalling Firm: Dispensing Solutions, Inc., Santa Ana, CA
Manufacturer: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT

REASON FOR RECALL

Labeling Mixup; incorrect product name on the information tab (side panel) on the product label

 

  • No pending recalls to report for the September 5th, 2012 Enforcement Report.
  • No pending recalls to report for the August 29th, 2012 Enforcement Report.
  • No pending recalls to report for the August 22th, 2012 Enforcement Report.
  • No pending recalls to report for the August 15th, 2012 Enforcement Report.
  • No pending recalls to report for the August 8th, 2012 Enforcement Report.
  • No pending recalls to report for the August 1st, 2012 Enforcement Report.
  • No pending recalls to report for the July 25th, 2012 Enforcement Report.

 

  • Pending recalls for the July 18th, 2012 Enforcement Report:

PRODUCT

Leucovorin Calcium Injection, USP, Sterile liquid, single use vials, 10mg/mL; 50mL per vial, Rx only, NDC# 55390-009-01 (Bedford), NDC# 55390-826-01(Novaplus)

CODE

Lot# 2017620, exp.1/31/2013, lot # 2038374, exp.2/28/2013 NDC #55390-009-01
Lot# 2038374A (packaged using Novaplus labeling) is a sublot of 2038374 (packaged using Bedford labeling) exp. 2/28/2013 NDC #55390-826-01

RECALLING FIRM/MANUFACTURER

Recalling Firm: Ben Venue Laboratories Inc, Bedford, Ohio
Manufacturer: Ben Venue Laboratories Inc, Bedford, Ohio

REASON FOR RECALL

Presence of Particulate matter:complaints of visible crystalline particulates.

 

PRODUCT

1) Carboplatin Injection, 10 mg/mL, 45 mL Multi-Dose Vial, Rx only, NDC 61703-339-50 (Hospira label), NDC 61703-360-50 (Novoplus label)
2) Cytarabine Injection, 20 mg/mL, 50 mL Single Dose Vial, Rx only, NDC 61703-303-46
3) Methotrexate Injection, 25 mg/mL, 40 mL Single Dose Vial, Rx only, NDC 61703-408-41
4) Paclitaxel Injection, 6 mg/mL, 50 mL Single Dose Vial, Rx only, NDC 61703-342-50
 
CODE
1) lot numbers Y061711AA, exp FEB 2013 and Y061711AB, exp FEB 2013
2) lot numbers Y131994AA, exp AUG 2013; Y141994AA, exp SEP 2013; Y151994AA, exp SEP 2013; Y161994AA, exp NOV 2013; Y171994AA, exp NOV 2013 and Y181994AA, exp NOV 2013
3) lot number Y064457AA, exp OCT 2013
4) lot numbers Y096865AA, exp AUG 2013; Y106865AA, exp AUG 2013; Y116865AA, exp AUG 2013; Y126865AA, exp SEP 2013; Y136865AA, exp SEP 2013; Y146865AA, exp SEP 2013; Y156865AA, exp OCT 2013; Y166865AA, exp NOV 2013; Y176865AA, exp NOV 2013; and Y186865AA, exp DEC 2013

RECALLING FIRM/MANUFACTURER

Recalling Firm: Hospira Inc., Lake Forest, Illinois
Manufacturer: Hospira Australia Pty, Mulgrave, Australia

REASON FOR RECALL

Presence of Particulate matter: Products are being recalled due to visible particles embedded in the glass located at the neck of the vial

 

PRODUCT

Zee brand Antiseptic Wipes (Benzalkonium chloride 0.133%), First Aid Antiseptic
 
CODE
Lots: JT23210, JT23210, JT25810, JT27610, JT31510, JT35610, JT04811, JT05311, JT11811, JT13211, JT15911, JT15911, JT15211, JT18211, JT18211, JT21511-1

RECALLING FIRM/MANUFACTURER

Recalling Firm: Dukal Corp, Ronkonkoma, NY
Manufacturer: Jiangsu Province, Jianerkang Medical Dressing Co., Jintan City, Jinagsu, China

REASON FOR RECALL

Microbial contamination of Non Sterile Product; product may be ontaminated with Burkholderia cepacia

 

PRODUCT

Xactdose Phenytoin Oral Suspension USP 125 mg/5mL unit dose cups, Rx only

CODE

Lot #'s 210900, 214000, 220100, 224800, 228700, 232800

RECALLING FIRM/MANUFACTURER

Recalling Firm: VistaPharm Inc., Largo, FL
Manufacturer: VistaPharm Inc, Largo, FL

REASON FOR RECALL

Defective container; lidding deformity

 

PRODUCT

Vecuronium Bromide for Inj, For IV use only, 20 mg per vial 10mg vials, Lyophilized Powder, Rx only NDC #55390-039-10.

CODE

Lot #2067134 Exp 5/31/2013

RECALLING FIRM/MANUFACTURER

Recalling Firm: Ben Venue Laboratories Inc., Bedford, OH
Manufacturer: Ben Venue Laboratories Inc., Bedford, OH

REASON FOR RECALL

Presence of Particulate Matter
 
  • No pending recalls to report for the July 11th, 2012 Enforcement Report.

 

  • Pending recalls for the July 5th, 2012 Enforcement Report:

PRODUCT

Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5mg/325mg per 15mL, 15 mL unit dose cups and 473 mL bottles, NDC 66689-023-50/66689-023-16

CODE

Lot #'s 251400 and 251500

RECALLING FIRM/MANUFACTURER

Recalling Firm: VistaPharm Inc., Largo, FL

Manufacturer: VistaPharm, Inc., Largo, FL

REASON FOR RECALL

Impurity/Degradation Products

 

PRODUCT

Kleenex Luxury Foam Hand Sanitizer, benzallkonium chloride 0.1%, 1 liter (33.8 fl oz) and 1.2 liter (40.5 fl oz) cassettes

CODE

SKU #12977-00 (Cassette - 1 Liter), Lost #:SA1229ANB; SKU#12979-00 (E-Cassette - 1.2 Liters), Lot #: SA1229ANA

RECALLING FIRM/MANUFACTURER

Recalling Firm: Kimberly-Clark Corporation, Roswell, GA

Manufacturer: Kimberly Clark Corporaton San Antonio Operations, San Antonio, TX

REASON FOR RECALL

Microbial Contamination of Non-Sterile products

 

PRODUCT

VMaxx Rx Capsules, All Natural Male Enhancement, 1 (UPC Code 2802803561) and 5 (UPC Code 0972859402) and 10 (UPC Code 0913251017) count packages

CODE

Single Count - Lot Nos.: 101108, 101009, 101010, 101011 Five Count - Lot Nos.: 101108, 101109, 101110 Ten Count, Lot Nos.: 301000, 301001

RECALLING FIRM/MANUFACTURER 

Recalling Firm: The Menz Club, Ridgeland, MS

Manufacturer: Chengdu Kangquan Halth Product Co., Ltd, Chengdu, China

REASON FOR RECALL

Marketed without an Approved NDA/ANDA; product found to contain sildenafil, an active ingredient used in a FDA approved drug product for erectile dysfunction

 

PRODUCT

Trizivir (abacavir sulfate 300 mg, lamivudine 150 mg and zidovudine 300 mg), 60 Tablets, NDC 49702-217-18, Rx only

CODE

Lot #0ZP5128

RECALLING FIRM/MANUFACTURER 

Recalling Firm: GlaxoSmithKline Inc, Zebulon, NC

Manufacturer: GlaxoSmithKline Inc., Zebulon, NC

REASON FOR RECALL

Label Mixup; bottles labeled to contain Trizivir Tablets actually contain Lexiva Tablets

 

 

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