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 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
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
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
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
- Qvar Inhalers (beclomethasone Dipropionate HFA) 40 mcg, 8.7g/120 metered inhalations, Rx only, NDC 59310-202-40
- Qvar Inhalers (beclomethasone Dipropionate HFA) 80 mcg, 8.7g/120 metered inhalations, Rx only, NDC 59310-204-80
CODE
- GNF013A, exp 6/2014, GNF069A, exp 6/2014 & GNG086A, exp 7/2014
- 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
- 2CV0627, Exp 11/13 and 2DV1239, Exp 10/13, UPC #: 345802303219
- 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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