• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Enforcement Report for November 30, 2011

 

November 30, 2011                                                                        11-48                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Nate's Spiced Prawns, six ounce (drained weight) product in 16 ounce glass jars. There are 12 jars per case. The UPC number is 0 27241 40069 7. Individual product jars is labeled as follows: "***NATE'S ORIGINAL Peel and Eat SPICED PRAWNS***6 oz. (170 G) Drained Weight***." Recall # F-0167-2012
CODE
Sell by dates: NOV-17-11, DEC-14-11, DEC-28-11, JAN-7-12, JAN-26-12, FEB-15-12, MAR-9-12, APRIL-4-12 and APRIL-25-12
RECALLING FIRM/MANUFACTURER
Pacific Oyster Co., Bay City, OR, by telephone on October 25, 2011, by placard posting on October 26, 2011 and by press release on October 29, 2011. FDA initiated recall is ongoing.
REASON
The product contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
873 pounds
DISTRIBUTION
OR, WA
___________________________________
PRODUCT
1) "PANGASINAN Smoked MACKEREL (HASA-HASA), Net Wt. 6oz. (170g)" 60 packages/case; UPC 22392 57470. Recall # F-0168-2012;
 
2) "PANGASINAN Smoked ROUND SCAD (TINAPANG GALUNGGONG), Net Wt. 6oz. (170g)", 60packages/case; UPC 2239257451. Recall # F-0169-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Foremost Foods International, Inc., Pomona, CA, by press release and letter on November 3, 2011.
Manufacturer: Fitrite Inc., Quezon City, Philippines. FDA initiated recall is ongoing.
REASON
The recall was initiated because Foremost Foods International has confirmed that the Pangasinan Roundscad Smoked Galunggong and the Pangasinan Mackerel Smoked Hasa Hasa are uneviscerated and may have the potential to be contaminated with Clostridium botulinum toxin.
VOLUME OF PRODUCT IN COMMERCE
320 cases
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
Apple Crisp in a bake-able black cup with a clear plastic lid. Net Wt. 6 oz. There is no UPC on a label. Label reads in part: "PORTLAND style CHEESECAKE & DESSERT Co.*** Apple Crisp***Net Wt. 6 oz.***Ingredients: Apples, Butter Blend, Unbleached Wheat Flour, Quick Oats, Br. Sugar, Sugar, Lemon Juice, Spices***Remove Lid, heat 30 seconds***Remove Lid, heat 350, 10 minutes***". Recall # F-0271-2012
CODE
Expiration Date: 10/28/11
RECALLING FIRM/MANUFACTURER
Portland Style Cheesecake & Dessert Co., Portland, OR, by telephone on October 17, 2011. FDA initiated recall is ongoing.
REASON
Butter was listed on the product label; however milk was not listed as a source for butter.
VOLUME OF PRODUCT IN COMMERCE
12 - 6 ounce units
DISTRIBUTION
OR
___________________________________
PRODUCT
Hawaiian King 70% cocoa Dark Chocolate Covered Whole Macadamia Nuts, Royales 15 chocolates (5 oz (141 gr) or 30 chocolates, 10 oz (282 gr). Ingredients: Chocolate liquor, Sugar, Cocoa Butter, Soy Lecithin as an emulsifier, Vanilla and dry roasted macadamia nuts. Manufactured in a facility that used macadamia nuts and other tree nuts. Recall # F-0272-2012
CODE
UPC 036778001666; Sell by 12 DEC 12, 20 NOV 12. 10 oz UPC 036778 001659; Se;; by 12 DEC 12; 3 DEC 12; 30 NOV 12, 20 NOV 12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hawaiian King Candies, Honolulu, HI, by telephone on November 2, 2011.
Manufacturer: Hawaiian King Candies, Honolulu, HI. FDA initiated recall is ongoing.
REASON
FDA inspection at facility found that dark chocolate covered nuts are made on the same equipment as milk chocolate without cleaning between runs and statement on package informing them of potential whey protein in the product.
VOLUME OF PRODUCT IN COMMERCE
38232 5 oz boxes; 33552 10 oz boxes
DISTRIBUTION
HI
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
1) Bimbo Donitas Chocolate Frosted 8 pack Donuts, 4.3 oz/122 grams, UPC 7432309964. Recall # F-0234-2012;
 
2) Bimbo Donitas Sugared 8 pack Donuts, 3.6 oz/102 grams, UPC 7432307039. Recall # F-0235-2012;
 
3) Bimbo Donitas Powdered 8 Pack Donuts, 4.0 oz/113 grams, UPC 7432304976. Recall # F-0236-2012;
 
4) Entenmann's - Pop 'ems Rich Frosted Donuts, 10.5 oz/298 grams, UPC 7203001571. Recall # F-0237-2012;
 
5) Entenmann's - Pop 'ems Cinnamon Donuts, 10 oz/284 grams, UPC 7203001985. Recall # F-0238-2012;
 
6) Entenmann's Pop 'Ems Powdered Donuts, 10 oz/284 grams, UPC 7203001570. Recall # F-0239-2012
CODE
Use by dates May 11, 12, 15, 18, 19, 22, 25, 26, 29, 2011; June 1, 2, 6, 2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bimbo USA, Horsham, PA, by Press release on May 10, 2011. 
Manufacturing Firm: Mary Ann's Baking Co Inc., Sacramento, CA. Firm initiated recall is ongoing.
REASON
Unpleasant odor, premature mold.
VOLUME OF PRODUCT IN COMMERCE
108,462
DISTRIBUTION
AZ, CA, ID, NV, UT, and WY
___________________________________
PRODUCT
Coca Cola, 12 fl. oz. cans (12 pack), Canned under the authority of the Coca Cola Bottling Company. Recall # F-0240-2012
CODE
JUL2312 CNC3, with time stamps between 10:30 and 14:30
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Coca-Cola Co., Atlanta, GA, by visit and letter on November 1, 2011.
Manufacturer: Coca Cola Co., Cincinnati, OH, Firm initiated recall is ongoing.
REASON
The specified 12 packs labeled as Coca Cola may contain Diet Coke cans filled with Coca Cola product, which has High Fructose Corn Syrup.
VOLUME OF PRODUCT IN COMMERCE
6,868 cases (24 cans per case)
DISTRIBUTION
OH, KY and IN
___________________________________
PRODUCT
Banana Nut Bread, Net Wt. 16 oz. (454g), wrapped in cellophane and packaged in a retail box. Recall # F-0241-2012
CODE
Lot # 11165, Lot # 11237
RECALLING FIRM/MANUFACTURER
Beatrice Bakery Co., Beatrice, NE, by telephone, e-mail or fax on November 3, 2011. Firm initiated recall is ongoing.
REASON
Lot # 11165 Lot # 11237
VOLUME OF PRODUCT IN COMMERCE
485 loaves/bread
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Nature Sweet Cherubs Sweet Snacking Tomatoes Net wt 10.5 oz (297g) Product of Mexico; WASH BEFORE EATING DO NOT REFRIGERATE. SKU: 7700. Recall #F-0265-2012
CODE
Package code: 2536B0564;
RECALLING FIRM/MANUFACTURER
Desert Glory LTD, San Antonio, TX, by email on June 27, 2011. Firm initiated recall is ongoing.
REASON
The amount of pesticide residue found is above EPA's established tolerance level.
VOLUME OF PRODUCT IN COMMERCE
59 cases
DISTRIBUTION
CO
 
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report17, published every Wednesday, to 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. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
 
RECALLS PENDING CLASSIFICATION: DRUGS
­­____________________________________________
PRODUCT
a) Albuterol Sulfate Extended-Release Tablets, 4 mg, 100-count tablets per bottle, Rx only, NDC 68774-400-01
 
b) VoSpire ER (albuterol sulfate) Extended-Release tablets, 4 mg, 6-count tablets per bottle, Rx only, NDC 68774-600-06, Patient Starter Pack.
CODE
a) Lot #: 7549012, Exp 08/12
 
b) Lot #: 7549012B, Exp 08/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: DAVA Pharmaceuticals, Inc., Fort Lee, NJ
Manufacturer: Pliva, Inc., East Hanover, NJ
REASON FOR RECALL
Failed Dissolution Test Requirements: These lots are being recalled due to a failure on stability test for dissolution at 19-months aging.
___________________________________________
PRODUCT
Hydroxyzine Pamoate capsules 50 mg, 500 count bottle, NDC 0591-0801-05
CODE
Lot:3087717 Exp 05/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Watson Labs Inc., Corona, CA
Manufacturer: Patheon Pharmaceuticals Inc., Cincinnati, OH
REASON FOR RECALL
cGMP Deviations; some capsules were found to have an additional cap over one-half of the capsule body. 
___________________________________________
PRODUCT
Cetirizine Hydrochloride Syrup, 1mg/1mL, 120mL and 480mL, Rx only, NDC 0603-9063-54 and NDC 0603-9063-58
CODE
Lot Numbers: L083A10A, exp. 02/12; L083A10B, exp. 02/12; L006C10A, exp. 03/12; L006C10B, exp. 03/12; L027C10A, exp. 04/12. L133C10A, exp. 04/12; L134C10A, exp. 04/12; L043D10A, exp. 04/12; L044D10A, exp. 06/12; L045D10A, exp. 06/12; L045D10B, exp. 06/12; L046D10B, exp. 06/12; L047D10A, exp. 06/12; L065E10A, exp. 06/12; L066E10A, exp. 06/12; L067E10A, exp. 06/12; L036F10A, exp. 07/12; L037F10A, exp. 07/12, L037F10B, exp. 07/12; L089G10A, exp. 08/12; L089G10B, exp. 08/12; L006H10B, exp. 08/12; L007H10A, exp. 08/12; L008H10A, exp. 08/12; L009H10A, exp. 09/12; L010H10A, exp. 09/12; L011H10A, exp. 10/12; L026H10A, exp. 10/12, L027H10A, exp. 10/12; L028H10A, exp. 10/12; L029H10A, exp. 10/12; L030H10A, exp. 10/12; L019J10A, exp. 10/12; L020J10A, exp. 10/12; L030J10A, exp. 10/12; L031J10A, exp. 10/12; L94J10A, exp. 11/12; L095J10A, exp. 11/12; L070K10A, exp.11/12; L071K10A, exp.11/12; L072K10A, exp. 11/12; L001L10A, exp. 11/12; L044L10A, exp. 12/12; L044L10B, exp. 12/12; L052L10A, exp. 11/12; L053L10A, exp. 11/12; L077L10A, exp. 12/12; L077L10B, exp. 12/12; L082L10A, exp. 01/13; L082L10B, exp. 01/13; L002M10A, exp. 12/12; L003M10A, exp.12/12; L003M10B, exp. 12/12; L012M10A, exp. 12/12; L013M10A, exp. 12/12; L038M10A, exp. 12/12; L022A11A, exp. 02/13; L022A11B, exp. 02/13; L023A11A, exp. 02/13; L023A11B, exp. 02/13; L024A11A, exp. 03/13; L037A11A, exp.03/13; L053A11A, exp. 02/13; L014C11A, exp.02/13; L132C11B, exp. 04/13; L044D11A, exp. 04/13; L063D11A, exp.05/13; L004F11A, exp. 05/13; L005F11A, exp. 05/13; L005F11B, exp. 05/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vintage Pharmaceuticals dba Qualitest Pharmaceuticals, Huntsville, AL
Manufacturer: Vintage Pharmaceuticals dba Qualitest Pharmaceuticals, Huntsville, AL
REASON FOR RECALL
Impurity Failure; 18 moth stability timepoint
_____________________________________________
PRODUCT
a) Children’s Panadol Liquid (acetaminophen) 80mg, ½ fl oz, 2 fl oz, and 4 fl oz bottles
 
b) Children’s Panadol Chewable Tablets (acetaminophen) 80mg, 32 count bottles
 
c) Infant’s Panadol Drops (acetaminophen) 80mg, ½ fl oz bottle with dropper
 
d) Panadol Cold & Flu (acetaminophen 500mg, chlorpheniramine maleate 2mg and phenylephrine HCl 5mg) 16 caplets and 2 pouchx50 packets/carton
 
e) Maximum Strength Contac Cold + Flu (acetaminophen 500mg, chlorpheniramine maleate 2mg and phenylephrine HCl 5mg), 30 packets, 2 caplets per packet
 
f) Children’s Mejoralito Liquid (acetaminophen) 80mg, 2 fl oz bottles
 
g) Children’s Mejoralito Chewable Tablets (acetaminophen) 80mg, 32 count bottle
 
h) Women’s Extra Strength Panadol, Menstrual Relief, Multi Symptom (acetaminophen 500mg and pamabrom 25mg
CODE
a) Code: Lot number 0910000169, Exp. Date: Oct 2011; UPC: 3-112843-21493-4, Lot: 0910000062, 0410000063, Exp. Date: Oct 2011, Lot: 0911000059, 0911000250, Exp. Date: Nov 2011, Lot: 1101000183, 1101000229, Exp. Date: Jan 2013, Lot:1103000366, Exp. Date; Feb 13, Lot: 1105000103, Exp. Date: May 2013; UPC: 3-12843-21494-1, Lot 0910000056, 0410000057, 0410000058, 090000059, 0910000245, 0410000246, 0910000247, 0910000248, Exp. Date: Oct 2011, Lot: 1101000184, 1101000185, 1101000230, Exp. Date: Jan 2013, Lot: 1103000367, 1103000368, Exp. Date: Mar 2013, Lot: 1106000405, Exp. Date Jun 2013
 
b) UPC: 3-09711-03140-3, Lot: PA015HE2, Exp. Date: May 2013; Lot: PA047FP1, Exp. Date: Dec 2012; Lot: PA047FP2, Exp. Date: Dec 2012
 
c) Code: UPC: 3-12843-21496-5, Lot: 0911000230, 0911000232, Exp. Date: Nov 2011 and 1105000118, May 2013
 
d) Code: UPC 3-09711-05005-3, Lot: PA009HD2, Exp. Date: Oct 2012; Lot PA027HE2, Exp. Date: Nov 2012, Lot: PA065FP, Exp. Date Jun 2012; UPC: 3-09711-05015-2, Lot: PA006AHC1, Exp. Date: Sept 2012, Lot PA007HA1, Exp. Date: Jul 2012, Lot: PA008HD1, Oct 2012, Lot: PA009HB1, Exp. Date: 2012, Lot PA009HE1, Exp. Date: Nov 2012, Lot: PA010HB1, Exp. Date: Aug 2012, Lot: PA016FD1, Exp. Date: Oct 2011, Lot: PA029HE1, Exp. Date: Nov 2012, Lot: PA069FP1, Exp. Date: Jun 2012, Lot: PA070FP1, Exp. Date: Jun 2012, Lot: PA102FD2, Exp. Oct 2011, Lot: PA101FD1, Exp. Date: Oct 2011, Lot: PA102FD1, Exp. Date: Oct 2011
 
e) Code; UPC: 3-09711-232405-7, Lot PA071FP1 and PA072FP1, Exp. Date: Jun 2012
 
f) Code: UPC: 0-53100-44310-9, Lot: 1105000465, Exp. Date: May 2013and Lot: 0911000100, Exp. Nov 2011
 
g) Code: UPC: 0-53100-44210-2, Lot: PA010HH2, Exp. Date 2013, Lot: PA011HE3, Exp. Date: May 2013, Lot: PA012HC2, Exp. Date: Mar 2013, Lot: PA064FP1, Exp. Date: Dec 2012 and Lot PA087FB1, Exp. Date: Feb 2012 and
 
h) Code; UPC 3-09711-21491-2, Lot: PA038EP1, Exp. Date: Dec 2011, Lot: PA073FP1, Exp. Date: Dec 2012; Lot: PA073FP2, Exp. Date: Dec 2012; Lot: PA085FB1, Exp. Date: Feb 2012 and Lot: PA098HC1, Exp. Date: Mar 2013.
RECALLING FIRM/MANUFACTURER
Recalling Firm: GlaxoSmithKline Inc., Zebulon, North Carolina
Manufacturer: GlaxoSmithKline Panama, SA, Panama, SA
REASON FOR RECALL
cGMP Deviations; Some of the analytical process validation activities did not contain primary data
_________________________________________
PRODUCT
5% Dextrose Injection USP, 250 mL Flexible Container, Rx only, NDC 0409-7922-02
CODE
Lot 95-067-JT, Exp May 2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL
Manufacturer: Hospira Inc., Austin, TX
REASON FOR RECALL
Lack of Assurance of Sterility; due to defective container
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
___________________________________
PRODUCT
Uprizing 2.0 (13-ethyl-3-methoxy-gona-2,5(10),-dien-17-one 30 mg; 4-Chloro-17a-Methyl-Androsta-1,4-diene-3,17-diol 17.5 mg; 2a 17a dimethyl etiocholan 3, one 17b-ol 10 mg) capsules, 90-count capsules per bottle; UPC: 2657061476. Recall # D-864-2012
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Superior Metabolic Technologies, Kennesaw, GA, by telephone and letter on August 5, 2011 and by press release on October 3, 2011. 
Manufacturer: Chaotic Labz. Dover, AR. FDA initiated recall is complete.
REASON
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain a synthetic steroid, making Uprizing 2.0 capsules an unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE
243 bottles
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
1) KETOCONAZOLE, 200 MG, TABLET, NDC 00093-0900-01, 51672-4026-06. Recall # D-494-2012;
 
2) KETOROLAC TROMETHAMINE, 10 MG, TABLET, NDC 00093-0314-01. Recall # D-495-2012;
 
3) LACOSAMIDE, 150 MG, TABLET, NDC 00131-2479-35. Recall # D-496-2012;
 
4) LACOSAMIDE, 50 MG, TABLET, NDC 00131-2477-35. Recall # D-497-2012;
 
5) LACTASE ENZYME, 3,000 UNITS, CAPLET, NDC 00904-5224-52. Recall # D-498-2012;
 
6) LACTASE ENZYME, 3,000 UNITS, TABLET, NDC 00536-4087-06. Recall # D-499-2012;
 
7) LACTASE ENZYME, CAPTAB, NDC 00536-7811-06. Recall # D-500-2012;
 
8) LACTASE ENZYME, TABLET, NDC 00536-4087-06, 00904-4324-25, 09045-0224-52. Recall # D-501-2012
 
9) LACTOBACILLIN ACIDOPHILUS, CAPSULE, NDC 00536-7180-01, 07985-4109-10, 43292-5002-02, 54629-0111-01. Recall # D-502-2012
 
10) LACTOBACILLUS, TABLET, NDC 08290-2368-50, 63736-0105-06, 64980-0129-50. Recall # D-503-2012;
 
11) LAMIVUDINE, 150 MG, TABLET, NDC 00173-0470-01, 49702-0203-18. Recall # D-504-2012;
 
12) LAMIVUDINE/ZIDOVUDINE, 150 MG/300 MG, TABLET, NDC 00173-0595-00.
Recall # D-505-2012;
 
13) lamoTRIgine, 100 MG, TABLET, NDC 68382-0008-01. Recall # D-506-2012;
 
14) lamoTRIgine, 150 MG, TABLET, NDC 00093-7247-06, 51672-4132-04, 68382-0009-14. Recall # D-507-2012;
 
15) lamoTRIgine, 200 MG, TABLET, NDC 68382-0010-14. Recall # D-508-2012;
 
16) lamoTRIgine, 25 MG, TABLET, NDC 00173-0633-02, 51672-4130-01, 55111-0220-01, 68382-0006-01. Recall # D-509-2012;
 
17) lamoTRIgine, 5 MG, CHEWABLE TABLET, NDC 00093-0688-01. Recall # D-510-2012;
 
18) LAMOTRIGINE ER, 100 MG, TABLET, NDC 00173-0756-00. Recall # D-511-2012;
 
19) LAMOTRIGINE EXTENDED RELEASE, 200 MG, TABLET, NDC 00173-0757-00. Recall # D-512-2012;
 
20) LANTHANUM CARBONATE, 1000 MG, CHEWABLE TABLET, NDC 54092-0254-10. Recall # D-513-2012;
 
21) LANTHANUM CARBONATE, 500 MG, CHEWABLE TABLET, NDC 54092-0252-45, 54092-0252-90. Recall # D-514-2012;
 
22) L-CARNITINE, 250 MG, CAPSULE, NDC 03504-6045-45, 35046-0004-54. Recall D-515-2012;
 
23) LEFLUNOMIDE, 20 MG, TABLET, NDC 00088-2161-30, 0093-0174-56, 66993-0161-30. Recall D-516-2012;
 
24) LETROZOLE, 2.5 MG, TABLET, NDC 00078-0249-15. Recall # D-517-2012;
 
25) 26) LEUCOVORIN CALCIUM, 5 MG, TABLET, NDC 00555-0484-01. Recall # D-519-2012;
 
27) LEVETIRACETAM, 100 MG/1 ML, ORAL SOLUTION, 5 ML/CUP, NDC 00054-0024-63. Recall # D-520-2012;
 
28) LEVETIRACETAM, 250 MG, TABLET, NDC 00378-5613-78, 13668-0014-12, 16252-0577-01, 50474-0594-40, 64376-0136-12, 68180-0112-16. Recall # D-521-2012;
 
29) LEVETIRACETAM, 500 MG, TABLET, NDC 00378-5615-78, 50474-0595-40, 64376-0137-90, 68180-0113-16. Recall D-522-2012;
 
30) LEVETIRACETAM, 750 MG, TABLET, NDC 64376-0138-12, 64376-0138-90. Recall # D-523-2012;
 
31) LEVETIRACETAM ER, 500 MG, TABLET, NDC 50474-0598-66. Recall # D-524-2012;
 
32) LEVOFLOXACIN, 250 MG, TABLET, NDC 50458-0920-50. Recall # D-525-2012;
 
33) LEVOFLOXACIN, 500 MG, TABLET, NDC 50458-0925-50. Recall # D-526-2012;
 
34) LEVOTHYROXINE SOD., 112 MCG (0.112 MG), TABLET, NDC 00074-9296-13, 00074-9296-90, 00378-1811-01, 00378-1811-10, 00527-1346-01. Recall # D-527-2012;
 
35) LEVOTHYROXINE SOD., 88 MCG, TABLET, NDC 00074-6594-13, 00378-1807-01, 00456-1329-01, 00527-1344-01, 00781-5183-01. Recall # D-528-2012;
 
36) LEVOTHYROXINE SODIUM, 100 MCG, TABLET, NDC 00074-6624-13, 00378-1809-10, 00456-1323-01. Recall # D-529-2012;
 
37) LEVOTHYROXINE SODIUM, 112 MCG, TABLET, NDC 00456-1330-01, 00781-5185-01, 60793-0885-01. Recall # D-530-2012;
 
38) LEVOTHYROXINE SODIUM, 112 MCG, TABLET, NDC 00378-1811-01. Recall # D-531-2012;
 
39) LEVOTHYROXINE SODIUM, 137 MCG, TABLET, NDC 00378-1823-01, 00456-1331-01, 00527-1638-01. Recall # D-532-2012;
 
40) LEVOTHYROXINE SODIUM, 150 MCG, TABLET, NDC 00378-1815-01, 00378-1815-10. Recall # D-533-2012;
 
41) LEVOTHYROXINE SODIUM, 175 MCG, TABLET, NDC 00074-7070-13, 00378-1817-01, 00456-1326-01, 00781-5188-01. Recall # D-534-2012;
 
42) LEVOTHYROXINE SODIUM, 200 MCG, TABLET, NDC 00378-1819-01, 00456-1327-01. Recall # D-535-2012;
 
43) LEVOTHYROXINE SODIUM, 25 MCG, TABLET, NDC 00074-4341-13, 00074-4341-90, 00378-1800-01, 00456-1320-01, 00527-1341-01, 00781-5180-01. Recall # D-536-2012;
 
44) LEVOTHYROXINE SODIUM, 300 MCG, TABLET, NDC 00074-7149-13. Recall # D-537-2012;
 
45) LEVOTHYROXINE SODIUM, 50 MCG, TABLET, NDC 00074-4552-13, 00378-1803-01, 00456-1321-01, 00527-1342-01, 00781-5181-01. Recall # D-538-2012;
 
46) LEVOTHYROXINE SODIUM, 75 MCG, TABLET, NDC 00456-1322-01, 00527-1343-01, 00781-5182-01. Recall # D-539-2012;
 
47) LIDOCAINE HCL, 4% TOPICAL, 40MG/ML, NDC 00054-3505-47, 60432-0465-50. Recall # D-540-2012;
 
48) LIOTHYRONINE SODIUM, 25 MCG, TABLET, NDC 00574-0222-01. Recall # D-541-2012;
 
49) LIOTHYRONINE SODIUM, 5 MCG, TABLET, NDC 00574-0220-01, 60793-0115-01. Recall # D-542-2012;
 
50) LIPASE/AMYLASE/PROTEASE, 20/109/68 UNITS, CAPSULE, NDC 42865-0103-02. Recall # D-543-2012;
 
51) LIPASE/AMYLASE/PROTEASE DR, 10,000/55,000/34,000 IU, CAPSULE, NDC 42865-0101-02. Recall # D-544-2012;
 
52) LISINOPRIL & HCTZ, 20 MG/25 MG, TABLET, NDC 68180-0520-01, 68180-0520-02. Recall # D-545-2012
 
53) LISINOPRIL, 10 MG, TABLET, NDC 00172-3759-70, 00378-2074-10, 00591-0407-01. Recall # D-546-2012;
 
54) LISINOPRIL, 2.5 MG, TABLET, NDC 00143-1265-01, 00172-3757-60, 00185-0025-01, 00378-2072-01, 00591-0405-01, 64679-0927-01, 68180-0512-01, 68180-0512-02. Recall # D-547-2012;
 
55) LISINOPRIL, 20 MG, TABLET, NDC 00172-3760-60, 00378-2075-10. Recall # D-548-2012;
 
56) LISINOPRIL, 40 MG, TABLET, NDC 00172-3761-60, 00591-0409-01, 64679-0942-01. Recall # D-549-2012;
 
57) LISINOPRIL, 5 MG, TABLET, NDC 00378-2073-01. Recall # D-550-2012;
 
58) LITHIUM CARBONATE, 300 MG, CAPSULE, NDC 00054-2527-25. Recall # D-551-2012;
 
59) LITHIUM CARBONATE ER, 300 MG, CAPSULE, NDC 00054-0021-05, 00054-0021-25, 00054-0024-25, 68968-4492-01. Recall # D-552-2012;
 
60) LITHIUM CARBONATE ER, 450 MG, TABLET, NDC 00054-0020-25, 00143-1277-01. Recall # D-553-2012;
 
61) LOPERAMIDE HCL, 2 MG, CAPSULE, NDC 00093-0311-01, 00093-0311-05, 00378-2100-01, 00378-2100-05. Recall # D-554-2012;
 
62) LOPINAVIR/RITONAVIR, 200/50 MG, TABLET, NDC 00074-6799-22. Recall # D-555-2012;
 
63) LORATADINE, 10 MG, TABLET, NDC 00067-6070-30, 00781-5077-01, 45802-0650-87, 49348-0818-12, 49348-0818-13. Recall # D-556-2012;
 
64) LORATADINE ORAL SOLUTION, 5 MG/5 ML, NDC 37205-0378-26. Recall # D-557-2012;
 
65) LORAZEPAM, 0.5 MG, TABLET, NDC 00228-2057-10. Recall # D-558-2012;
 
66) LORAZEPAM, 1 MG, TABLET, NDC 00904-6008-60, 63304-0773-10. Recall # D-559-2012;
 
67) LORazepam, 2 MG/ML, LIQUID, NDC 11111-0001-18. Recall # D-560-2012;
 
68) LORAZEPAM INTENSOL, 2 MG/ML, CONCENTRATION, NDC 00054-3532-44. Recall # D-561-2012;
 
69) LORSARTAN POTASSIUM, 100 MG, TABLET, NDC 00093-7366-98. Recall # D-562-2012;
 
70) LORSARTAN POTASSIUM, 25 MG, TABLET, NDC 00093-7364-98, 00781-5805-92, 16714-0581-02, 16714-0582-01, 16714-0582-02. Recall # D-563-2012;
 
71) LORSARTAN POTASSIUM, 50 MG, TABLET, NDC 00093-7365-10, 00093-7365-56, 00093-7365-98, 00781-5701-31, 00781-5701-92, 00781-5806-31, 00781-5806-92, 16714-0582-02, 59762-0071-02. Recall # D-564-2012;
 
72) LOSARTAN POTASSIUM-HCTZ, 50/12.5 MG, TABLET, NDC 00781-5207-92, 16714-0226-01. Recall # D-565-2012;
 
73) LOVASTATIN, 40 MG, TABLET, NDC 00185-0074-01. Recall # D-566-2012;
 
74) LOXAPINE, 10 MG, CAPSULE, NDC 00591-0370-01. Recall # D-567-2012;
 
75) LOXAPINE, 25 MG, CAPSULE, NDC 00591-0371-01. Recall # D-568-2012;
 
76) LOXAPINE, 5 MG, CAPSULE, NDC 00591-0369-01. Recall # D-569-2012;
 
77) LUBIPROSTONE, 24 MCG, CAPSULE, NDC 64764-0240-60. Recall # D-570-2012
 
78) MAGNESIUM CHLORIDE, 64 MG, TABLET, NDC 06858-0005-75, 68585-0005-74, 68585-0005-75. Recall # D-571-2012;
 
79) MAGNESIUM CHLORIDE DR, 64 MG, TABLET, NDC 00904-7911-52. Recall # D-572-2012;
 
80) MAGNESIUM HYDROXIDE, 400 MG/5 ML, SUSPENSION, NDC 00904-0788-16. Recall # D-573-2012;
 
81) MAGNESIUM/CALCIUM, 71.5/119 MG, TABLET, NDC 67618-0107-60. Recall # D-574-2012;
 
82) MAGNESIUM/PHOSPHORUS/CALCIUM, 54 MG/132 MG/175 MG, TABLET, NDC 00256-0172-01. Recall # D-575-2012;
 
83) MAGONATE, LIQUID, NDC 00256-0184-07. Recall # D-576-2012;
 
84) MECLIZINE HCL, 12.5 MG, TABLET, NDC 00536-3985-01. Recall # D-577-2012;
 
85) MECLIZINE HCL, 25 MG, TABLET, NDC 49884-0035-01, 59746-0121-06. Recall # D-578-2012;
 
86) MECLOFENAMATE SODIUM, 100 MG, CAPSULE, NDC 00378-3000-01. Recall # D-579-2012;
 
87) MedroxyPROGESTERone ACETATE, 10 MG, TABLET, NDC 00555-0779-04, 59762-3742-02. Recall # D-580-2012;
 
88) MedroxyPROGESTERone ACETATE, 2.5 MG, TABLET, NDC 59762-3740-01, 59762-3740-05. Recall # D-581-2012;
 
89) MEDROXY-PROGESTERONE ACETATE, 5 MG, TABLET, NDC 59762-3741-01. Recall # D-582-2012;
 
90) MEGESTROL ACETATE, 20 MG, TABLET, NDC 00555-0606-02, 49884-0289-01. Recall # D-583-2012;
 
91) MEGESTROL ACETATE, 40 MG, TABLET, NDC 00555-0607-02. Recall # D-584-2012;
 
92) MEGESTROL ACETATE, 625 MG/5 ML, SUSPENSION, NDC 49884-0949-69. Recall # D-585-2012;
 
93) MEGESTROL ACETATE ORAL SUSPENSION, 40 MG/ML, NDC 00054-3542-58, 49884-0907-61. Recall # D-586-2012;
 
94) MELATONIN, 1 MG, TABLET, NDC 47469-0004-66, 74312-0028-32. Recall # D-587-2012;
 
95) MELATONIN, 3 MG, TABLET, NDC 03076-8486-78, 04746-9160-68, 04934-8098-10, 40985-0212-40, 47469-0160-68, 51991-0014-06, 74312-0079-01. Recall # D-588-2012;
 
96) MELOXICAM, 7.5 MG, TABLET, NDC 68180-0501-01. Recall # D-589-2012;
 
97) MELPHALAN, 2 MG, TABLET, NDC 00173-0045-35. Recall # D-590-2012;
 
98) MEMANTINE HCL, 10 MG, TABLET, NDC 00456-3210-60. Recall # D-591-2012;
 
99)MEMANTINE HCL, 2 MG/ML, SOLUTION, NDC 00456-3202-12. Recall # D-592-2012;
 
100) MENTHOL COUGH SUPPRESSANT, LOZENGE, NDC 63736-0859-46. Recall # D-593-2012;
 
101) MERCAPTOPURINE, 50 MG, TABLET, NDC 00054-4581-01, 00054-4581-11, 49884-0922-02. Recall # D-594-2012;
 
102) MESALAMINE CR, 250 MG, CAPSULE, NDC 54092-0189-81. Recall # D-595-2012;
 
103) MESALAMINE DR, 400 MG, TABLET, NDC 00149-0752-15. Recall # D-596-2012;
 
104) METAXALONE, 800 MG, TABLET, NDC 60793-0136-01, 64720-0321-10. Recall # D-597-2012;
 
105) METFORMIN, 500 MG, TABLET, NDC 00093-1048-01, 00378-0234-01, 57664-0397-51. Recall # D-598-2012;
 
106) METFORMIN HCL, 1000 MG, TABLET, NDC 00378-0244-01, 57664-0474-58, 65162-0177-11, 65162-0177-50. Recall # D-599-2012;
 
107) METFORMIN HCL, 850 MG, TABLET, NDC 00093-1049-01, 57664-0435-58. Recall # D-600-2012;
 
108) METFORMIN HCL ER, 1000 MG, TABLET, NDC 59630-0575-60. Recall # D-601-2012;
 
109) METFORMIN HCL ER, 500 MG, TABLET, NDC 62756-0142-01. Recall # D-602-2012;
 
110) MetFORMIN HYDROCHLORIDE, 500 MG, TABLET, NDC 00093-1048-01, 00904-5849-80, 57664-0397-51, 57664-0397-53, 62037-0571-01, 65162-0175-10, 65162-0175-50, 68382-0028-01, 68468-0159-05. Recall # D-603-2012;
 
111) METHAZOLAMIDE, 50 MG, TABLET, NDC 48102-0101-01. Recall # D-604-2012;
 
112) METHENAMINE HIPPURATE, 1 G, TABLET, NDC 64720-0139-10. Recall # D-605-2012;
 
113) METHIMAZOLE, 10 MG, TABLET, NDC 00185-0210-01, 49884-0641-01. Recall # D-606-2012;
 
114) METHIMAZOLE, 5 MG, TABLET, NDC 00185-0205-01, 49884-0640-01. Recall # D-607-2012;
 
115) METHOCARBAMOL, 500 MG, TABLET, NDC 00603-4485-21. Recall # D-608-2012;
 
116) METHOCARBAMOL, 750 MG, TABLET, NDC 00603-4486-21. Recall # D-609-2012:
 
117) METHOTREXATE, 2.5 MG, TABLET, NDC 00054-4550-25. Recall # D-610-2012;
 
118) METHSUXIMIDE, 300 MG, CAPSULE, NDC 00071-0525-24. Recall # D-611-2012;
 
119) METHYLDOPA, 250 MG, TABLET, NDC 00378-0611-01. Recall # D-612-2012;
 
120) METHYLERGONOVINE MALEATE, 0.2MG, TABLET, NDC 00078-0054-05. Recall # D-613-2012;
 
121) METHYLPREDNISOLONE, 2 MG, TABLET, NDC 00009-0049-02. Recall # D-614-2012;
 
122) MethylPREDNIsolone, 4 MG, TABLET, NDC 00781-5022-01, 00781-5022-07, 59476-0001-06. Recall # D-615-2012;
 
123) METOCLOPIRAMIDE, 5 MG/5 ML, ORAL SOLUTION, NDC 60432-0622-16. Recall # D-616-2012
 
124) METOCLOPIRAMIDE, 10 MG, TABLET, NDC 16714-0062-04. Recall # D-617-2012;
 
125) METOLAZONE, 10 MG, TABLET, NDC 65580-0645-71. Recall # D-618-2012;
 
126) METOLAZONE, 2.5 MG, TABLET, NDC 65580-0643-71. Recall # D-619-2012;
 
127) METOPROLOL, 50 MG, TABLET, NDC 00093-0733-01. Recall # D-620-2012;
 
128) METOPROLOL SUCCINATE ER, 100 MG, TABLET, NDC 49884-0406-01, 62037-0832-01. Recall # D-621-2012;
 
129) METOPROLOL SUCCINATE ER, 200 MG, TABLET, TABLET, NDC 49884-0407-01. Recall # D-622-2012;
 
130) METOPROLOL SUCCINATE ER, 25 MG, TABLET, NDC 49884-0404-01. Recall # D-623-2012;
 
131) METOPROLOL SUCCINATE ER, 50 MG, TABLET, NDC 49884-0405-01, 9884-0405-10, 62037-0831-01. Recall # D-624-2012;
 
132) METOPROLOL TARTRATE, 25 MG, TABLET, NDC 00378-0018-01, 57664-0477-52, 57664-0506-52, 57664-0506-58. Recall # D-625-2012;
 
133) METRONIDAZOLE, 250 MG, TABLET, NDC 00591-3970-50, 00904-1453-61, 50111-0333-01, 50111-0334-01, 50111-0334-02. Recall # D-626-2012;
 
134) MEXILETINE HCL, 150 MG, CAPSULE, NDC 00093-8739-01. Recall # D-627-2012;
 
135) MEXILETINE HCL, 200 MG, CAPSULE, NDC 00093-8740-01. Recall # D-628-2012;
 
136) MEXILETINE HYDROCHLORIDE, 250 MG, CAPSULE, NDC 00093-8741-01. Recall # D-629-2012;
 
137) MICRONIZED COLESTIPOL HCL, 1 G, TABLET, NDC 59762-0450-01. Recall # D-630-2012;
 
138) MIDAZOLAM HYDROCHLORIDE, 2 MG/1 ML, 5 ML/SYRINGE, NDC 00054-3566-99, 00574-0150-04, 63304-0205-18. Recall # D-631-2012;
 
139) MIDODRINE HCL, 10 MG, TABLET, NDC 00015-4233-01, 00115-4233-01.
Recall # D-632-2012;
 
140) MIDODRINE HCL, 2.5 MG, TABLET, NDC 00115-4211-01, 00185-0040-01. Recall # D-633-2012;
 
141) MIDODRINE HCL, 5 MG, TABLET, NDC 00185-0043-01. Recall # D-634-2012;
 
142) MIGLITOL, 50 MG, TABLET, NDC 00009-5013-01. Recall # D-635-2012;
 
143) MINOCYCLINE HYDROCHLORIDE, 100 MG, CAPSULE, NDC 63304-0696-50. Recall # D-636-2012;
 
144) MINOCYCLINE HYDROCHLORIDE, 50 MG, CAPSULE, NDC 00591-5694-01, 63304-0694-01. Recall # D-637-2012;
 
145) MINOXIDIL, 10 MG, TABLET, NDC 00591-5643-01. Recall # D-638-2012:
 
146) MINOXIDIL, 2.5 MG, TABLET, NDC 00591-5642-01, 53489-0386-01. Recall # D-639-2012;
 
147) MIRTAZAPINE, 15 MG, TABLET, NDC 00093-7206-56, 00378-3515-93. Recall # D-640-2012;
 
148) MISOPROSTOL, 100 MCG, TABLET, NDC 00172-4430-49, 00172-4430-59. Recall # D-641-2012;
 
149) MISOPROSTOL, 200 MCG, TABLET, NDC 00172-4431-49, 00172-4431-60, 59762-5008-01. Recall # D-642-2012;
 
 
150) MODAFINIL, 100 MG, TABLET, NDC 06345-9201-30, 63459-0101-01, 63459-0101-30. Recall # D-643-2012;
 
151) MODAFINIL, 200 MG, TABLET, NDC 63459-0201-30. Recall # D-644-2012;
 
152) MOEXIPRIL, 7.5 MG, TABLET, NDC 00093-0017-01. Recall # D-645-2012;
 
153) MOEXIPRIL HCL, 15 MG, TABLET, NDC 00574-0112-15. Recall # D-646-2012;
 
154) MONTELUKAST SODIUM, 10 MG, TABLET, NDC 00006-0117-31, 00006-0117-54. Recall # D-647-2012 ;
 
155) MONTELUKAST SODIUM, 4 MG, CHEWABLE TABLET, NDC 00006-0117-31. Recall # D-648-2012;
 
156) MONTELUKAST SODIUM, 5 MG, CHEWABLE TABLET, NDC 00006-0275-31. Recall # D-649-2012;
 
157) MONTELUKAST SODIUM CHEWABLE, 4 MG, TABLET, NDC 00006-0711-31. Recall # D-650-2012;
 
158) MSM/GLUCOSAMINE, 500 MG/500 MG, TABLET, NDC 47469-0161-28. Recall # D-651-2012;
 
159) MULTIVIT/MIN/LUTEIN_PRESERVISION, NDC 24208-0632-10. Recall # D-652-2012;
 
160) MULTIVITAIN/MULTIMINERAL HIGH POTENCY, TABLET, NDC 00904-5042-60, 54629-0082-01. Recall # D-653-2012;
 
161) MULTIVITAMIN W/ LUTEIN - CENTRUM SILVER, TABLET, NDC 00904-5486-52, 00904-5486-89. Recall # D-654-2012;
 
162) MULTIVITAMIN/MINERAL AQUADEKS, TABLET, NDC 58914-0014-60. Recall # D-655-2012;
 
163) MULTIVITAMIN/MINERAL CENTRUM, TABLET, NDC 00005-4755-70. Recall # D-656-2012;
 
164) MULTIVITAMIN/MULTIMINERAL (CENTRUM), LIQUID, NDC 00536-2790-59. Recall # D-657-2012;
 
165) MULTIVITAMIN/MULTIMINERAL, HIGH POTENCY, LIQUID, NDC 54838-0010-70. Recall # D-658-2012;
 
166) MULTIVITAMIN-OCULAR I-VITE, TABLET, NDC 00536-5090-08. Recall # D-659-2012;
 
167) MULTIVITAMINS, LIQUID, NDC 00536-8450-80, 54838-0008-70. Recall # D-660-2012;
 
168) MULTIVITAMINS, TABLET, NDC 00536-4046-10, 00536-4660-38. Recall # D-661-2012;
 
169) MULTIVITAMINS W/ZINC ADEKS, TABLET, NDC 58914-0010-06. Recall # D-662-2012;
 
170) MULTIVITAMINS W/ZINC DIALYVITE, TABLET, NDC 10542-0012-10. Recall # D-663-2012;
 
171) MULTIVITAMINS/MINERALS W/IRON, TABLET, NDC 00904-5339-60. Recall # D-664-2012;
 
172) MULTIVITAMINS/MINERALS/IRON/BETA-CAROTENE (DAILY-VITE), TABLET, NDC 00536-3546-01, 00536-3546-10. Recall # D-665-2012;
 
173) MULTIVITAMINS/MULTIMINERAL, TABLET, NDC 00005-4758-70, 00536-3442-38, 00536-3445-08, 00536-4661-38, 57896-0531-01. Recall # D-666-2012;
 
174) MULTIVITAMIN THERA-PLUS, NDC 05038-3683-04, 50383-0683-04. Recall # D-667-2012;
 
175) MYCOPHENOLATE MOFETIL, 250 MG, CAPSULE, NDC 00004-0259-01, 00004-0259-43, 00781-2067-01. Recall # D-668-2012; 
 
176) MYCOPHENOLATE MOFETIL, 500 MG, TABLET, NDC 00004-0260-01, 00004-0260-43. Recall # D-669-2012;
 
177) MYCOPHENOLATE SODIUM DR, 360 MG, TABLET, NDC 00078-0386-66. Recall # D-670-2012;
 
178) MYCOPHENOLIC ACID, 180 MG, TABLET, NDC 00078-0385-66. Recall # D-671-2012;
 
179) LACTOBACILLUS CAPSULE, NDC 43292-5002-02. Recall # D-672-2012
CODE
1) Lot: 30213487A, Exp 02/02/12; 105962, Exp 08/12/11;
 
2) Lot: 30212498a, Exp 11/11/11;
 
3) Lot: 57740, Exp 02/18/12, 05/03/12, 05/15/12; 0925802, Exp 02/07/12, 04/27/12;
 
4) Lot: 55854, Exp 12/16/11; 57319, Exp 05/17/12; 0944103, Exp 12/06/11, 12/16/11; '0944103, Exp 10/18/11;
 
5) Lot: 0DR0259, Exp 08/06/11; OGR0220, Exp 09/14/11; OLR0288, Exp 05/12/12; OMR0216, Exp 03/28/12;
 
6) Lot: 07310150, Exp 11/24/11, 12/09/11; 08310170, Exp 11/24/11, 12/09/11, 01/19/12; 0241 9021, Exp 08/11/11, 09/24/11, 10/07/11; 0731 0150, Exp 09/24/11, 10/22/11, 11/08/11, 11/11/11, 11/24/11, 12/08/11, 10/22/11, 10/25/11, 10/28/11; 0831 0170, Exp 11/24/11, 12/08/11, 12/27/11, 01/11/12, 01/26/12, 01/31/12, 02/09/12, 02/18/12, 02/28/12, 03/06/12, 03/17/12, 03/21/12, 04/13/12, 04/18/12, 04/28/12, 05/05/12;
 
7) Lot: 1481 9090, Exp 06/25/11;
 
8) Lot: 08310170, Exp 05/19/12; 9371502, Exp 08/25/11; 19371502, Exp 06/02/11, 06/08/11, 06/22/11, 07/07/11, 08/03/11, 09/02/11, 09/28/11, 10/31/11; 19371510, Exp 07/22/11, 08/03/11, 10/14/11, 10/31/11; 29120404, Exp 10/14/11, 10/27/11, 12/21/11, 03/01/12; 29977902, Exp 10/27/11, 11/10/11; 29977904, Exp 12/13/11, 12/21/11, 01/19/12; 31190202, Exp 03/01/12; 31190206, Exp 03/01/12, 04/07/12; 118906506, Exp 08/31/11; 0JR0350, Exp 01/18/12;
 
9) Lot: 0471 0101, Exp 05/19/12; 01A32, Exp 11/17/11; 0HA67, Exp 11/17/11; 341287, Exp 04/19/12; 341335, Exp 04/19/12; 0AB27, Exp 08/11/11; 0JB47, Exp 01/14/12; 9LB16, Exp 06/25/11; OKB04, Exp 03/21/12;
 
10) Lot: 169273, Exp 08/27/11; 0298769, Exp 12/02/11; 298769, Exp 02/03/12; 0321604, Exp 12/17/11, 12/28/11; 0333181, Exp 02/24/12; 0337514, Exp 04/11/12; O235928, Exp 11/17/11; 42329, Exp 11/30/11; 40999, Exp 10/27/11; 7168-65, Exp 06/03/11; 7168-67, Exp 12/07/11, 01/31/12, 03/31/12; 7168-70, Exp 08/25/11; 7168-71, Exp 12/07/11; 7168-72, Exp 08/25/11, 12/07/11, 12/21/11, 12/29/11; 7168-74, Exp 01/31/12, 02/14/12, 03/09/12; 7168-76, Exp 12/29/11, 01/25/12, 01/26/12, 01/31/12; 7168-77, Exp 03/24/12; 7168-78, Exp 03/06/12, 03/09/12, 03/30/12, 05/08/12; 7168-79, Exp 04/13/12, 04/17/12, 04/19/12, 04/25/12, 05/08/12, 05/10/12, 05/18/12, 05/19/12; 7168-80, Exp 03/24/12, 03/30/12, 04/13/12, 04/19/12, 04/25/12, 05/08/12, 05/10/12, 05/18/12, 05/19/12;
 
11) Lot: 0ZP0263, Exp 09/23/11; 0ZP0893, Exp 10/25/11; OA002, Exp 07/06/11, 08/16/11, 10/11/11; 'OB003, Exp 07/06/11; OZP0893, Exp 11/24/11, 01/04/12; OZP6932, Exp 08/30/11, 09/10/11; 0ZP3975, Exp 01/27/12; 1ZP6077, Exp 03/15/12, 04/06/12, 04/27/12; 1ZP8205, Exp 04/27/12, 05/04/12;
 
12) Lot: 9ZP6804, Exp 04/10/12; OZP2523, Exp 08/18/11, 08/19/11; OZP4563, Exp 06/30/11;
 
13) Lot: MK1813, Exp 07/23/11; MK2940, Exp 08/16/11; MK2942, Exp 09/10/11; MK3597, Exp 10/21/11; MK4444, Exp 11/19/11; MK5520, Exp 12/21/11, 12/22/11, 01/13/12; MK6293, Exp 01/21/12; MK7102, Exp 02/11/12; MK9197, Exp 03/22/12; MK9198, Exp 04/10/12;
 
14) Lot: 11L067, Exp 06/30/11; 11L068, Exp 06/30/11; 11L069, Exp 06/30/11; 11L070, Exp 06/30/11; 11L076, Exp 12/31/11; 11L081, Exp 11/19/11; 11L083, Exp 02/16/12; 11L084, Exp 12/21/11; 11L085, Exp 03/20/12; 11L087, Exp 04/18/12; 11L088, Exp 04/10/12; 107036, Exp 11/04/11; MJ6460, Exp 08/18/11;
 
15) Lot: MK1817, Exp 08/16/11; MK2043, Exp 08/20/11; MK2944, Exp 09/07/11, 09/15/11, 09/20/11; MK3602, Exp 10/07/11, 10/18/11; MK4447, Exp 10/29/11; MK6297, Exp 11/05/11, 11/19/11; MK6299, Exp 01/11/12; MK7206, Exp 02/21/12, 02/25/12; MK8526, Exp 03/16/12, 05/19/12; MK8821, Exp 03/02/12; ML1152, Exp 04/10/12; ML2620, Exp 05/05/12, 05/19/12;
 
16) Lot: 9ZP2747, Exp 01/21/12, 02/09/12; A05847, Exp 02/09/12; C101412, Exp 04/21/12; MK5383, Exp 12/16/11; MK7849, Exp 02/07/12; MK9195, Exp 04/25/12, 05/08/12;
 
17)Lot: 05L010, Exp 07/31/11.
 
18) Lot: 1ZP8897, Exp 05/18/12;
 
19) Lot: OZP1566, Exp 11/10/11;
 
20) Lot: A55096A, Exp 02/28/12;
 
21) Lot: A54061A, Exp 11/03/11; A55082A, Exp 06/22/11; A55083A, Exp 07/16/11; A57911A, Exp 08/24/11; A59758A, Exp 11/03/11; A60081A, Exp 11/03/11; A60988A, Exp 12/08/11, 12/13/11; A63624A, Exp 12/08/11, 12/21/11; A63625A, Exp 03/13/12; A64751A, Exp 03/13/12; A64753A, Exp 03/16/12; A65984A, Exp 03/14/12; A44916B, Exp 05/31/11; A54060A, Exp 08/04/11; A597758A, Exp 11/04/11; A60990A, Exp 11/04/11; A63625A, Exp 05/02/12; A63626A, Exp 02/03/12, 02/15/12; A64751A, Exp 02/15/12, 02/22/12; A65754A, Exp 05/10/12; A65755A, Exp 04/13/12, 04/21/12; A65984A, Exp 04/19/12; A66333A, Exp 05/17/12;
 
22) Lot: 0208F0, Exp 05/03/12, 10/14/11, 11/24/11, 12/22/11, 01/11/12, 01/21/12, 01/27/12, 01/28/12; '0208FO, Exp 10/28/11; '0323A0, Exp 09/03/11, 09/10/11; 0465AB, Exp 10/14/11; O323AO, Exp 09/13/11;
 
23) Lot: 0HN2C, Exp 05/10/12; 30210800A, Exp 06/10/11; ODF8A, Exp 11/09/11;
 
24) Lot: F4267, Exp 06/18/11; F4271, Exp 07/15/11; F4274, Exp 08/11/11, 08/23/11; F4276, Exp 09/09/11; F4279, Exp 10/28/11; F4280, Exp 10/29/11; F4281, Exp 10/15/11; F4282, Exp 10/29/11, 11/30/11; F4284, Exp 12/08/11; F4290, 01/11/12; F4294, Exp 03/22/12, 03/28/12; F4298, Exp 03/06/12, 05/05/12;
 
25) Lot: 34000361A, Exp 03/29/12;
 
26) Lot: 314624, Exp 06/10/11, 06/15/11; 316852, Exp 02/22/12.
27) Lot: 061899A, Exp 02/16/12; 159220A, Exp 04/27/12; 159362A, Exp 04/17/12;
 
28) Lot: 2001435, Exp 07/31/11; 3015383, Exp 06/23/11, 07/21/11; 3015877, Exp 07/30/11; 3017701, Exp 11/03/11, 11/18/11, 12/15/11, 01/05/12; 3021074, Exp 01/18/12; 3021075, Exp 02/16/12; BE369002, Exp 05/31/11; BS181, Exp 09/30/11; 57867, Exp 04/27/12; G08534, Exp 11/24/11; 3021076, Exp 03/30/12; 3102649, Exp 10/21/11;
 
29) Lot: 302998, Exp 02/14/12; 2001066, Exp 05/31/11; 3014394, Exp 07/30/11; 3015500, Exp 05/28/11; 3015503, Exp 06/09/11, 06/23/11; 3017772, Exp 08/11/11, 08/17/11; 3017775, Exp 07/09/11; 3018086, Exp 09/02/11; 3018087, Exp 09/08/11, 09/09/11; 3018089, Exp 09/16/11; 3018090, Exp 10/06/11; 3020279, Exp 10/22/11; 3020280, Exp 11/18/11; 3020283, Exp 10/29/11; 3021265, Exp 11/22/11, 11/30/11; 3021268, Exp 12/21/11; 3021271, Exp 12/28/11, 01/06/12; 3022999, Exp 02/22/12; 3024419, Exp 03/28/12; 55048, Exp 06/18/11, 07/08/11; 55380, Exp 08/24/11; 56482, Exp 11/30/11; 56943, Exp 01/05/12; 57535, Exp 02/04/12; 57706, Exp 04/27/12; G09073, Exp 03/20/12; 3110914, Exp 05/08/12;
 
30) Lot: G06887, Exp 11/24/11, 12/31/11; G06970, Exp 08/12/11, 09/07/11, 09/20/11;
 
31) Lot: 58778, Exp 05/18/12;
 
32) Lot: 0LG263, Exp 02/16/12, 03/17/12; OKG105, Exp 12/16/11;
 
33) Lot: OGG884, Exp 02/29/12; OKG161, Exp 12/06/11;
 
34) Lot: 01004A8, Exp 03/16/12; 02154A8, Exp 04/21/12; 92008A8, Exp 11/03/11; 93128A8, Exp 11/26/11; 3016225, Exp 06/18/11, 06/21/11; 3016673, Exp 07/29/11, 07/30/11; 3017957, Exp 09/23/11; 3017959, Exp 10/15/11, 10/18/11; 3020990, Exp 01/05/12; 3020991, Exp 02/02/12, 02/03/12; 3022717, Exp 02/02/12, 02/29/12, 03/08/12; 3025099, Exp 03/28/12; 3025101, Exp 04/19/12, 05/04/12; 3016670, Exp 07/28/11; 000211, Exp 02/23/12, 04/19/12; 023710, Exp 12/08/11, 12/20/11, 05/10/12;
 
35) Lot: 01123A8, Exp 03/31/12; 93116A8, Exp 11/20/11; 3016663, Exp 07/06/11; 3016666, Exp 08/17/11; 3016667, Exp 08/31/11; 3018452, Exp 10/29/11; 3018454, Exp 01/25/12, 01/26/12; 3019494, Exp 10/21/11; 3020985, Exp 12/27/11, 12/28/11, 01/07/12; 3020987, Exp 01/12/12; 3020988, Exp 01/28/12; 3022515, Exp 02/17/12, 02/22/12; 3022517, Exp 03/15/12, 03/20/12, 03/28/12; 3024370, Exp 04/14/12; 3024371, Exp 05/12/12; 3024372, Exp 05/05/12, 05/19/12; 1077362, Exp 05/31/11; 1079116, Exp 07/31/11; 1081566, Exp 09/30/11; 1084021, Exp 12/31/11; 1086950, Exp 05/17/12, 05/18/12; 003111, Exp 03/28/12, 04/19/12, 05/03/12, 05/09/12; 020710, Exp 11/19/11; 23909, Exp 08/17/11; 023910, Exp 01/31/12, 03/14/12, 05/08/12; 10T11261A, Exp 05/02/12; C10T0041A1, Exp 06/25/11;
 
36) Lot: 3020714, 01/26/12; 94337A8, Exp 12/01/11; 3020714, Exp 01/25/12; 1078792, Exp 12/07/11;
 
 37) Lot: 1074939, Exp 09/30/11; 1077364, Exp 11/30/11; 1077876, Exp 12/06/11, 12/09/11, 12/14/11; 1077877, Exp 01/04/12, 02/09/12; 1082492, Exp 03/15/12, 04/13/12; C10T0021A1, Exp 06/29/11; C10T0181A2, Exp 12/03/11; 60882, Exp 03/31/12;
 
38) Lot: 3026467, Exp 05/17/12;
 
39) Lot: 3017162, Exp 08/11/11; 3023751, Exp 03/31/12; 1077455, Exp 07/22/11, 08/23/11, 09/14/11, 09/22/11; 1080440, Exp 02/28/12; 1082495, Exp 04/30/12; 003811, Exp 03/28/12; 009111, Exp 05/15/12; 014710, Exp 12/20/11; 023810, Exp 01/21/12;
 
40) Lot: 3016661, Exp 06/30/11: 3019007, Exp 01/25/12, 01/26/12;
 
41) Lot: 95301A8, Exp 01/30/12; 3016466, Exp 07/08/11; 3017842, Exp 09/09/11, 09/15/11; 3017843, Exp 08/24/11; 3020263, Exp 01/11/12; 3020264, Exp 02/09/12, 02/17/12; 3025102, Exp 04/13/12, 04/21/12; 3025104, Exp 05/12/12, 05/16/12; 1078379, Exp 10/14/11, 11/19/11; 11/24/11; 1078380, Exp 12/31/11; 1080443, Exp 02/28/12; 10T9021A, Exp 03/15/12, 03/20/12;
 
42) Lot: 3013754, Exp 06/25/11; 3017623, Exp 08/11/11; 3017624, Exp 10/15/11; 1078381, Exp 12/06/11, 12/07/11;
 
43) Lot: 01176A8, Exp 04/13/12; 90086A8, Exp 06/01/11; 91102A8, Exp 09/30/11, 10/13/11; 92094A8, Exp 11/10/11; 93179A8, Exp 11/27/11; 95189A8, Exp 02/09/12; 96068A8, Exp 02/29/12; 03151A8, Exp 05/03/12; 3023350, Exp 02/21/12; 3023355, Exp 05/04/12, 05/09/12; 1081290, Exp 05/31/11; 008011, Exp 04/19/12; 009211, Exp 05/08/12; 026010, Exp 04/19/12; 11T0701A, Exp 05/17/12; 11T1721A, Exp 05/17/12;
 
 44) Lot: 90327A8, Exp 06/21/11; 
 
45) Lot: 02318A8, Exp 04/13/12; 3027077, Exp 05/09/12; 1081292, Exp 09/30/11; 003311, Exp 05/05/12; 11T1751A, Exp 05/02/12;
 
46) Lot: 1078790, Exp 07/31/11; 005611, Exp 04/25/12; 10T10691A, Exp 04/17/12;
 
47) Lot: 059499A, Exp 07/30/11; '059500A, Exp 09/02/11; 060339A, Exp 10/18/11; '060425A, Exp 10/29/11; 060426A, Exp 12/21/11, 02/14/12, 02/23/12, 03/09/12; 060984A, Exp 03/03/12, 03/21/12, 03/30/12; 060985A, Exp 03/28/12, 04/07/12, 04/11/12, 04/18/12, 04/28/12, 05/10/12, 05/12/12, 05/17/12; 958176A, Exp 06/10/11, 06/25/11; 958661A, Exp 09/25/11; 30503A, Exp 11/24/11; 30534A, Exp 12/20/11, 01/05/12, 01/13/12; 30569A, Exp 02/11/12, 02/24/12; 30640A, Exp 03/30/12; 30762A, Exp 04/19/12, 05/03/12;
 
48) Lot: 0C532, Exp 06/30/11; '0C532, Exp 06/30/11; 0G576, Exp 09/30/11; 0J597, Exp 11/30/11; 0J598, Exp 11/30/11; 0M650, Exp 03/31/12; OC531, Exp 06/30/11; OC532, Exp 06/30/11; OG575, Exp 09/30/11;
 
49) Lot: 11D556, Exp 05/15/12; OK623, Exp 02/25/12, 03/06/12; 59162, Exp 11/18/11; 60646, Exp 02/18/12;
 
50) Lot: 104539, Exp 01/21/12; 110015, Exp 05/01/12, 05/08/12; 095909C, Exp 07/21/11; 103903B, Exp 11/19/11;
 
51) Lot: 103949A, Exp 01/04/12; 104538A, Exp 03/21/12;
 
52) Lot: 3104706, Exp 01/27/12, 01/28/12; 3104708, Exp 02/03/12; 3104710, Exp 02/24/12; 3104715, Exp 02/28/12; 3105300, Exp 03/23/12, 03/24/12, 03/27/12, 03/28/12, 03/29/12; 3110722, Exp 04/27/12, 04/28/12, 05/03/12, 05/08/12; 3101210, Exp 06/07/11; 3101906, Exp 07/28/11; 3102164, Exp 07/28/11; 3102460, Exp 09/02/11; 3103186, Exp 09/30/11; 3103675, Exp 12/28/11; 3104326, Exp 12/02/11;
 
53) Lot: 24009, Exp 06/30/11; 33402027A, Exp 07/31/11; 33402536A, Exp 06/07/11, 07/28/11, 09/02/11, 09/30/11; 33402975B, Exp 09/30/11; 1040435, Exp 01/28/12; 1045344, Exp 02/29/12; 308636A, Exp 01/13/12;
 
54) Lot: 64452B, Exp 01/12/12; TE01124A, Exp 09/07/11; TE04123, Exp 10/07/11; TE04149, Exp 10/21/11, 10/29/11, 11/11/11, 11/17/11, 11/18/11, 11/30/11; TE05191, Exp 11/22/11, 11/30/11, 12/28/11; TE05192, Exp 03/28/12, 03/30/12; TE12084, Exp 05/05/12, 05/18/12; BJ7592, Exp 03/20/12; 1033089, Exp 09/16/11; 1033090, Exp 10/11/11, 11/23/11; 1033091, Exp 12/14/11, 12/20/11, 12/29/11, 01/26/12, 01/31/12, 02/08/12, 02/09/12; 1047485, Exp 04/28/12, 05/18/12; 327840A, Exp 03/15/12, 04/04/12; DL10368, Exp 05/10/12; 3102917, Exp 02/09/12; 3104494, Exp 03/15/12, 05/04/12; 3102304, Exp 12/28/11; 3110581, Exp 04/11/12;
 
55) Lot: TE11139, Exp 04/26/12; 1041984, Exp 02/29/12;
 
56) Lot: TE09210, Exp 03/01/12; 309528A, Exp 01/13/12; DK10425, Exp 02/28/12;
 
57) Lot: 3018704, Exp 02/29/12;
 
58) Lot: 061033A, Exp 03/30/12;
 
59) Lot: 059251A, Exp 06/15/11; 059254A, Exp 06/25/11, 06/15/11; '059254A, Exp 06/24/11; '059361A, Exp 09/10/11, 09/14/11, 09/24/11; 059362A, Exp 08/11/11; '059363A, Exp 08/26/11; 059366A, Exp 10/15/11; 059729A, Exp 11/10/11, 11/23/11, 11/24/11, 12/06/11, 12/15/11; 059730A, Exp 10/15/11, 12/08/11; 059843A, Exp 01/04/12, 02/09/12; 059844A, Exp 12/14/11, 12/28/11, 01/25/12, 02/09/12; 059887A, Exp 01/26/12; 059888A, Exp 01/21/12; 059891A, Exp 02/22/12, 02/28/12; 061139A, Exp 03/15/12; 061141D, Exp 04/18/12, 05/03/12; 061424A, Exp 03/15/12, 03/21/12; 061425A, Exp 05/08/12, 05/12/12, 05/17/12; 061426A, Exp 04/12/12; 958630A, Exp 06/25/11, 06/29/11; 958631A, Exp 07/19/11; 958632A, Exp 08/23/11; O59366A, Exp 11/03/11; O59731A, Exp 11/11/11; O59732A, Exp 11/24/11; O59845A, Exp 01/11/12; '059730A, Exp 10/18/11; 500610, Exp 03/01/12;
 
60) Lot: 061749A, Exp 02/18/12, 02/23/12, 02/24/12; 061750B, Exp 03/08/12; 159278A, Exp 04/27/12; 67172A, Exp 06/17/11; 67786A, Exp 08/17/11; 67788A, Exp 06/17/11, 07/15/11, 07/26/11; 67828A, Exp 09/07/11; 67934A, Exp 10/15/11; 67980A, Exp 11/02/11; 68034A, Exp 11/30/11; 68103A, Exp 12/22/11, 12/28/11, 01/11/12; 68166A, Exp 03/15/12; 68735A, Exp 04/27/12;
 
61) Lot: 0P566, Exp 02/03/12; 30212108A, Exp 09/15/11; 30213744A, Exp 02/04/12; 30214754A, Exp 05/02/12, 05/19/12; 30211619, Exp 11/12/11; 30214720A, Exp 03/29/12, 04/17/12; 3W0074, Exp 09/10/11; 3W1136, Exp 03/06/12;
 
62) Lot: 02344AA, Exp 04/14/12; 87005AA, Exp 07/14/11;
 
63) Lot: 10107030, Exp 05/01/12; 195535, Exp 06/07/11; 195536, Exp 06/30/11; 195763, Exp 07/28/11; 198345, Exp 09/02/11; 198350, Exp 09/30/11; 198788, Exp 06/07/11; 198789, Exp 06/30/11; 198790, Exp 06/30/11; 1968344, Exp 12/30/11; OFE1883, Exp 08/17/11; OFE2121, Exp 09/22/11; OFE2392, Exp 08/17/11, 09/09/11, 09/22/11; 0FE2123, Exp 10/12/11; 0LE1535, Exp 02/21/12;
 
64) Lot: 108595, Exp 04/18/12;
 
65) Lot: 073A11, Exp 04/12/12; 410K01, Exp 12/30/11, 02/02/12;
 
66) Lot: L 2236A, Exp 01/20/12; L 2625, Exp 04/07/12; L 2672, Exp 05/12/12; L2204, Exp 11/12/11; 2203903, Exp 03/06/12;
 
67) Lot: 061284A, 03/22/12;
 
68) Lot: 059339A, Exp 11/08/11; 061020A, Exp 01/26/12; 061284A, Exp 03/30/12; 159160A, Exp 04/12/12, 05/10/12; 958244A, Exp 07/15/11;
 
69) Lot: L66056, Exp 07/27/11; 
 
70) Lot: L67018, Exp 06/16/11; L67030, Exp 08/18/11, 08/30/11, 09/07/11, 09/17/11; L67032, Exp 09/30/11, 10/11/11; L67060, Exp 11/19/11, 01/07/12, 02/04/12, 03/03/12; L67061, Exp 09/23/11, 11/18/11, 12/02/11, 01/18/12, 01/25/12; L67081, Exp 02/03/12; L67084, Exp 01/26/12; L67099, Exp 02/03/12; L67103, Exp 04/19/12; E005431, Exp 07/02/11; E007583, Exp 12/21/11; E007584, Exp 09/24/11; E008134, Exp 12/14/11; E008135, Exp 12/07/11, 12/21/11, 01/07/12; Z1908, Exp 04/04/12; G00043A, Exp 12/27/11, 12/28/11; G00045A, Exp 01/31/12; G00337A, Exp 03/09/12, 03/15/12, 03/23/12; G00491A, Exp 05/01/12, 05/05/12; G00493A, Exp 04/12/12; G00041A, Exp 10/13/11; G00400A, Exp 02/11/12, 03/14/12; G00401A, Exp 03/14/12; G00464A, Exp 04/11/12; G00467A, Exp 04/11/12; G00124A, Exp 04/27/12; G00125A, Exp 02/11/12; G00126A, Exp 10/18/11; g00126a, Exp 11/04/11, 11/11/11; G00127A, Exp 12/02/11, 12/08/11, 12/17/11, 12/27/11, 12/28/11, 01/10/12, 01/25/12, 02/04/12; G00167A, Exp 05/01/12; G00450A, Exp 02/09/12, 03/13/12, 03/21/12, 04/03/12; G00465A, Exp 04/18/12; G00547A, Exp 05/05/12; G00567A, Exp 05/10/12;
 
71) Lot: L65119, Exp 03/15/12; L65089, Exp 01/03/12; L65128, Exp 01/11/12; 40L015, Exp 02/04/12; 40L016, Exp 03/10/12; 40L044, Exp 04/25/12; L65031, Exp 06/14/11, 06/17/11; L65036, Exp 09/07/11; L65039, Exp 07/28/11, 09/13/11, 09/14/11; L65063, Exp 06/25/11; L65064, Exp 07/06/11; L65065, Exp 07/27/11; L65066, Exp 08/17/11; L65076, Exp 10/21/11; L65077, Exp 09/24/11, 09/29/11; L65078, Exp 11/26/11; L65079, Exp 10/06/11, 10/25/11; L65113, Exp 01/10/12; L65132, Exp 01/10/12, 02/09/12; L65134, Exp 02/04/12, 02/09/12; BD00909, Exp 04/10/12; BC4595, Exp 01/11/12, 01/17/12, 02/02/12; BD0887, Exp 02/15/12; E006899, Exp 08/30/11; E007458, Exp 09/13/11, 09/21/11; E009074, Exp 10/21/11, 10/28/11, 11/11/11, 11/19/11, 12/08/11; E009302, Exp 07/31/11; E005210, Exp 07/08/11; E005212, Exp 05/27/11, 06/03/11, 06/15/11, 07/02/11; E006356, Exp 09/07/11; E006896, Exp 08/06/11; E008447, Exp 10/11/11; E008477, Exp 09/30/11, 10/07/11; E009302, Exp 10/31/11; G00567A, Exp 05/17/12; LB5010004-B, Exp 04/18/12;
 
72) Lot: BA8255, Exp 02/04/12; KF5010009-A, Exp 03/01/12; KF5010010-A, Exp 04/10/12;
 
73) Lot: 200441, Exp 10/25/11;
 
74) Lot: 283308A, Exp 08/16/11; 327894A, Exp 04/12/12;
 
75) Lot: 49931A, Exp 02/22/12;
 
76) Lot: 1109500454, Exp 06/17/11, 07/15/11, 07/23/11, 09/07/11, 09/21/11, 10/15/11, 11/02/11, 11/24/11, 01/26/12; 1109500524, Exp 03/28/12; 108094A, Exp 08/16/11;
 
77) Lot: 108720661, Exp 01/25/12, 01/26/12; 1129122-61, Exp 04/27/12; 998884-61, Exp 07/07/11;
 
78) Lot: A006W, Exp 08/11/11; A019W, Exp 12/31/11; A002W, Exp 05/27/11; A005W, Exp 07/26/11; A006W, Exp 08/24/11; A010W, Exp 09/13/11; A011W, Exp 10/12/11; A013W, Exp 10/28/11; A015W, Exp 11/18/11 11/24/11; A016W, Exp 12/08/11, 12/31/11; A017W, Exp 12/21/11, 12/27/11; A020W, Exp 12/31/11; A021W, Exp 12/31/11; A022W, Exp 12/31/11; A102W, Exp 10/19/11; L009W, Exp 03/23/12; L011W, Exp 04/11/12; L012W, Exp 04/13/12, 04/18/12, 04/24/12, 05/03/12;
 
79) Lot: K112U, Exp 06/03/11, 07/06/11, 10/15/11; K115U, Exp 10/15/11, 10/29/11; K123U, Exp 12/31/11; L010W, Exp 05/19/12; L018U, Exp 01/31/12, 05/16/12;
 
80) Lot: JMR044, Exp 12/07/11;
 
81) Lot: B007WA, Exp 01/20/12; B037WA, Exp 01/31/12; B051WA, Exp 12/30/11;
 
82) Lot: 1002705, Exp 04/12/12;
 
83) Lot: 1002401, Exp 07/13/11; 1002707, Exp 03/21/12;
 
84) Lot: 10D250, Exp 09/22/11; 10D254, Exp 10/07/11; 10G478, Exp 12/08/11; 10H645, Exp 12/08/11; 10H648, Exp 03/27/12; 10J703, Exp 02/10/12; 10L871, Exp 03/21/12; 10L874, Exp 04/25/12;
 
85) Lot: 22531601, Exp 08/05/11; 22531801, Exp 12/10/11; 22532301, Exp 09/09/11; 22534801, Exp 09/22/11; 22867602, Exp 04/19/12; 22868901, Exp 04/24/12; 0P258, Exp 12/08/11; 1P051, Exp 03/16/1286);
 
 86) Lot: 3015200, Exp 02/29/12;
 
87) Lot: 311615, Exp 06/07/11; 312641, Exp 09/02/11; C091239, Exp 06/07/11, 09/27/11; C100325, Exp 10/11/11, 11/05/11; C100810, Exp 12/30/11, 01/27/12, 02/24/12, 03/23/12; 
 
88) Lot: C091188, Exp 09/30/11, 10/21/11; C100567, Exp 09/02/11, 09/30/11, 11/05/11, 12/30/11, 01/03/12, 01/11/12; C101404, Exp 03/09/12, 03/27/12, 04/10/12, 05/08/12; C100324, Exp 12/02/11;
 
89) Lot: C090974, Exp 09/10/11, 12/06/11, 04/11/12;
 
90) Lot: 317462, Exp 02/29/12; 22609801, Exp 01/11/12;
 
91) Lot: 703451, Exp 02/29/12;
 
92) Lot: 22532501, Exp 11/04/11; 22532602, Exp 12/08/11, 01/13/12; 22697201, Exp 01/13/12; 22792901, Exp 11/04/11; 22793001, Exp 12/08/11; 22907401, Exp 03/13/12;
 
93) Lot: 159200A, Exp 05/17/12; 22432501, Exp 06/04/11, 06/11/11, 07/01/11;
 
94) Lot: 2042513, Exp 06/02/11, 08/16/11; 2043395, Exp 09/20/11, 11/05/11, 12/08/11; 2044619, Exp 03/13/12; 328763-03, Exp 05/18/12; 331151-01, Exp 05/18/12;
 
95) Lot: 325491-04, Exp 03/09/12; 325491-22, Exp 05/05/12; 2045572, Exp 04/13/12; 2045835, Exp 05/19/12; 325491-18, Exp 03/24/12; 5362000, Exp 05/05/12; 5473500, Exp 04/19/12; 5473501, Exp 05/05/12; 5548800, Exp 05/05/12; 2041995, Exp 06/02/11, 06/10/11, 06/21/11, 07/20/11; 2043058, Exp 07/01/11, 07/07/11; 2043459, Exp 07/28/11, 08/13/11, 09/07/11; 2043799, Exp 09/07/11; 2044326, Exp 10/25/11, 11/19/11; 2044673, Exp 11/11/11, 04/10/12; 2044902, Exp 12/14/11, 01/11/12, 02/09/12; 2045572, Exp 03/15/12; 101629, Exp 11/18/11, 12/23/11, 04/13/12; 102193, Exp 05/16/12; 102446, Exp 03/15/12, 03/22/12, 03/29/12, 03/31/12, 04/10/12, 04/17/12, 04/24/12, 05/01/12; 111345, Exp 05/12/12, 05/18/12; 334888-01, Exp 05/03/12, 05/05/12;
 
96) Lot: 3102267, Exp 03/03/12;
 
97) Lot: 008464, Exp 12/27/11;
 
98) Lot: A186843, Exp 01/18/12;
 
99) Lot: 1082281, Exp 03/23/12;
 
100) Lot: 10E13, Exp 04/03/12;
 
101) Lot: 060435A, Exp 12/27/11; O60434A, Exp11/30/11; 061623A, Exp 05/08/12; 10C020, Exp 11/24/11;
 
102) Lot: 0L8514, Exp 04/10/12; 0P8801, Exp 04/19/12, 05/01/12; 9A5546, Exp 04/10/12;
 
103) Lot: 40999, Exp 09/30/11; 441210 S3, Exp 06/18/11; 441565 S2, Exp 06/02/11; 441565 S4, Exp 07/01/11; 441753 S3, Exp 07/06/11; 441754 S2, Exp 06/25/11; 441754 S3, Exp 06/29/11; 441961 S1, Exp 07/22/11; 441962 S1, Exp 06/02/11; 442184 S2, Exp 08/26/11; 442368 S1, Exp 08/03/11; 442369 S1, Exp 08/31/11; 443026 S3, Exp 11/05/11; 443120 S2, Exp 09/17/11; 443121 S1, Exp 09/28/11; 443124 S4, Exp 09/28/11; 443128 S2, Exp 10/29/11; 443165 S1, Exp 10/21/11; 443198 S4, Exp 10/26/11; 443199 S4, Exp 10/08/11; 443204S3, Exp 10/13/11; 443205 S4, Exp 11/24/11; 443239 S1, Exp 11/30/11; 443544 S4, Exp 12/03/11; 443552 S1, Exp 12/17/11; 443561 S1, Exp 11/12/11; 443562 S1, Exp 11/10/11; 443673 S1, Exp 01/18/12; 443691 S3, Exp 02/22/12; 443691 S4, Exp 02/18/12; 443694 S1, Exp 02/02/12; 443694 S3, Exp 02/09/12; 443884 S3, Exp 01/05/12; 443885 S3, Exp 02/25/12; 443886 S4, Exp 03/07/12; 443890 S2, Exp 03/29/12; 443891 S3, Exp 03/08/12; 443892 S1, Exp 03/09/12; 443893 S1, Exp 03/31/12; 443896 S2, Exp 01/11/12; 444147 S2, Exp 12/30/11, 01/03/12; 444278 S1, Exp 04/19/12; 444281 S2, Exp 04/24/12, 05/10/12; 444284 S1, Exp 03/31/12; 444288 S2, Exp 04/19/12, 04/24/12; 444290 S4, Exp 04/04/12, 04/06/12; 444297 S4, Exp 05/12/12; 444298 S4, Exp 05/03/12; 444300 S2, Exp 05/09/12; 444302 S2, Exp 05/12/12; 444303 S2, Exp 02/11/12; 444305 S4, Exp 02/14/12; 444313 S2, Exp 03/08/12; 444314 S3, Exp 04/13/12; 
 
104) Lot: 102561, Exp 10/08/11; 103581, Exp 11/30/11; 104105, Exp 02/25/12; 104106, Exp 03/14/12; 105983, Exp 03/28/12, 04/04/12, 05/17/12; 105987, Exp 05/05/12; 105988, Exp 05/10/12; 105324, Exp 12/14/11; 106292, Exp 05/18/12;
 
105) Lot: TE08049, Exp 05/19/12; 3010036, Exp 01/13/12; JKK0342A, Exp 05/15/12; 
 
106) Lot: 3010040, Exp 07/20/11, 08/06/11, 09/10/11; 3010041, Exp 06/16/11, 07/20/11, 08/06/11; JKJ1628A, Exp 12/20/11; HC47110, Exp 09/23/11; HE06010, Exp 08/16/11; HE06110, Exp 08/30/11; HF30110, Exp 09/07/11; HF30610, Exp 10/22/11; HF30710, Exp 10/15/11; HH05009, Exp 06/23/11, 07/01/11; HH19510, Exp 11/19/11; HJ08409, Exp 07/14/11;
 
107) Lot: TE9Z019, Exp 07/29/11; JKJ2496B, Exp 11/30/11, 12/22/11, 02/23/12; JKJ2940A, Exp 01/31/12, 02/23/12;
 
108) Lot: 219326A, Exp 07/31/11; 275843M, Exp 09/23/11, 11/30/11, 12/22/11; 299858A, Exp 03/28/12; 337204M, Exp 05/05/12;
 
109) Lot: JKJ3085A, Exp 01/31/12;
 
110) Lot: TE08049, Exp 03/06/12, 03/21/12, 04/12/12, 05/09/12, 05/15/12; 198861, Exp 09/30/11; L 2196, Exp 09/02/11; L2171, Exp 06/07/11; JKJ0608A, Exp 08/13/11; JKJ2118A, Exp 12/27/11; JKK0342A, Exp 04/03/12, 04/10/12; JKK0491A, Exp 05/15/12, 05/19/12; 267772M, Exp 07/08/11; HK28010, Exp 12/07/11; ML1312, Exp 04/07/12; HH03209, Exp 07/28/11; HK20809, Exp 06/30/11; MK9273, Exp 03/27/12; 02102412, Exp 03/23/12;
 
111) Lot: E100211B, Exp 04/28/12;
 
112) Lot: 102800, Exp 06/18/11;
 
113) Lot: 188885, Exp 06/03/11; 22530201, Exp 09/22/11;
 
114) Lot: 198495, Exp 11/24/11, 12/27/11; 203689, Exp 12/27/11; 22480301, Exp 06/25/11; 22529501, Exp 10/25/11; 22535301, Exp 10/01/11; 22672601, Exp 12/07/11, 02/03/12; 22769101, Exp 02/09/12, 02/23/12, 02/24/12, 02/29/12;
 
115) Lot: T047H10A, Exp 11/24/11;
 
116) Lot: T092B10A, Exp 06/08/11; T096B10A, Exp 02/29/12; T118K10A, Exp 01/26/12;
 
117) Lot: 059029A, Exp 05/27/11;
 
118) Lot: 171, Exp 06/18/11, 10/31/11; 1003, Exp 11/03/11;
 
119) Lot: 3015427, Exp 08/17/11;
 
120) Lot: F0126, Exp 06/30/11; F0127, Exp 09/16/11, 10/12/11, 10/29/11; F0128, Exp 12/10/11; F0128L1, Exp 02/29/12; F0131, Exp 04/19/12;
 
121) Lot: OA1KX, Exp 02/29/12;
 
122) Lot: BP0762, Exp 05/11/12, 05/17/12; 204613, Exp 01/28/12; 1P002, Exp 02/22/12; OP248, Exp 02/29/12;
 
123) Lot: 30658A, Exp 04/14/12;
 
124) Lot: 73578, Exp 01/18/12;
 
125) Lot: 55002, Exp 04/19/12;
 
126) Lot: 56060, Exp 11/03/11;
 
127) Lot: TE9X135, Exp 10/31/11;
 
128) Lot: WB0074, Exp 08/11/11; WB0102, Exp 06/17/11; WF0120, Exp 09/09/11; WH0093, Exp 12/06/11; WK0050, Exp 04/27/12; 329418A, Exp 11/30/11; 365760A, Exp 02/02/12;
 
129) Lot: WC0037, Exp 07/14/11; WJ0112, Exp 11/18/11; WK0029, Exp 12/17/11;
 
130) Lot: TN0011, Exp 06/18/11; TN0059, Exp 07/29/11, 08/06/11, 08/11/11; TP0018, Exp 11/05/11, 12/08/11, 12/23/11, 01/07/12, 01/21/12, 02/15/12; TP0076, Exp 09/23/11; TT0024, Exp 11/11/11; WH0107, Exp 01/31/12, 03/01/12; WJ0039, Exp 03/07/12, 04/27/12; WJ0110, Exp 03/29/12, 04/13/12;
 
131) Lot: TM0096, Exp 06/04/11, 06/16/11, 06/17/11; TM0137, Exp 07/02/11, 08/06/11; TN0012, Exp 09/01/11, 09/23/11, 09/30/11, 10/20/11; TN0049, Exp 10/27/11, 11/11/11, 11/24/11, 11/30/11, 12/15/11, 12/28/11, 01/10/12, 01/21/12; TN0073, Exp 02/09/12, 02/15/12; TP0033, Exp 02/22/12, 02/25/12, 05/04/12; TP0077, Exp 03/15/12, 03/29/12; 22503801, Exp 07/28/11; 351551A, Exp 01/07/12; 388221A, Exp 04/26/12;
 
132) Lot: 3016697, Exp 10/25/11; 3017377, Exp 08/24/11; 3019384, Exp 12/10/11; 3020981, Exp 01/06/12; 3021394, Exp 02/11/12, 02/18/12; 3024173, Exp 04/11/12, 04/18/12, 04/27/12; 3024175, Exp 05/08/12; 3024177, Exp 05/18/12, 05/19/12; GKJ1276, Exp 03/27/12; GKJ0012, Exp 07/09/11, 07/28/11, 08/12/11, 08/30/11, 09/10/11, 10/07/11; GKJ0172, Exp 11/24/11; GKJ0638B, Exp 01/19/12; GKJ0899, Exp 03/10/12; GKK0121, Exp 04/19/12, 05/05/12; GKK0326, Exp 05/16/12; GKJ1154, Exp 02/29/12;
 
133) Lot: 30214774A, Exp 03/27/12; P-14184, Exp 08/05/11; 14233210A, Exp 03/29/12; 14204210A, Exp 03/23/12; 14211510A, Exp 05/04/12; 315136, Exp 06/07/11; 315185, Exp 06/07/11; 315187, Exp 06/07/11; 315191, Exp 06/30/11; 315500, Exp 09/02/11; 315840, Exp 09/02/11; 316097, Exp 09/30/11; 317333, Exp 03/03/12;
 
134) Lot: 35316577A, Exp 03/29/12, 05/09/12;
 
135) Lot: 35314847A, Exp 06/14/11;
 
136) Lot: 35201587A, Exp 05/03/12; 35314837A, Exp 06/09/11, 08/23/11; 35315494A, Exp 10/13/11; 35315496A, Exp 11/18/11;
 
137) Lot: 1001319, Exp 06/15/11; 1004785, Exp 02/29/12;
 
138) Lot: 059399A, Exp 07/10/11, 07/15/11; '059399A, Exp 09/15/11; 059591A, Exp 07/14/11; '059591A, Exp 06/30/11, 07/01/11; 059762A, Exp 08/30/11; 060225A, Exp 12/28/11, 02/02/12, 02/24/12, 03/30/12; 060226A, Exp 03/30/12, 04/21/12; 061303A, Exp 04/21/12, 05/12/12; 958770A, Exp 07/10/11, 07/15/11; O59399A, Exp 11/23/11; 29990, Exp 06/10/11; 130783, Exp 08/20/11; 171075, Exp 08/20/11, 10/26/11; 0171075, Exp 12/28/11; 0352675, Exp 04/06/12; '0060277, Exp 06/24/11; '0130783, Exp 10/18/11; '0171075, Exp 10/18/11; E090235A, Exp 06/08/11; G090323A, Exp 06/10/11, 06/15/11, 07/10/11; J090421A, Exp 06/18/11, 07/10/11, 09/28/11, 10/09/11; J090422A, Exp 10/15/11; K0904824, Exp 12/04/11; K090482A, Exp 10/26/11, 10/31/11, 11/23/11, 12/04/11;
 
139) Lot: H0030021, Exp 06/08/11; H0071301, Exp 10/26/11, 11/08/11; H0071311, Exp 11/08/11; H0081141, Exp 01/07/12; H0081151, Exp 03/15/12; H0100521, Exp 02/17/12, 03/15/12, 03/16/12; H0100551, Exp 05/16/12;
 
140) Lot: H0040571, Exp 07/22/11; H0040581, Exp 09/24/11; H0051271, Exp 09/20/11, 09/24/11; H0051281, Exp 09/24/11; H0100351, Exp 03/16/12; H0100361, Exp 03/16/12; H9120901, Exp 07/26/11; 199057, Exp 01/13/12; 204955, Exp 03/28/12;
 
141) Lot: 199753, Exp 10/08/11; 201983, Exp 11/03/11, 12/08/11; 204446, Exp 01/04/12, 02/02/12; 204447, Exp 03/28/12, 04/27/12.
 
142) Lot: 5401RRJ, Exp 08/31/11;
 
143) Lot: 2137118, Exp 12/10/11;
 
144) Lot: 1110500792, Exp 03/07/12; 317725M, Exp 11/10/11; 2118470, Exp 12/27/11;
 
145) Lot: 276961A, Exp 08/05/11, 11/30/11; 309503A, Exp 03/31/12;
 
146) Lot: 284112M, Exp 07/30/11, 11/11/11; 299260A, Exp 11/30/11,02/28/12; 64685, Exp 03/16/12.
 
147) Lot: 742098, Exp 09/17/11, 10/28/11; 742110, Exp 04/27/12; 742114, Exp 03/28/12; 742118, Exp 05/04/12, 05/17/12; 3017725, Exp 07/28/11.
 
148) Lot: BFA28A, Exp 09/15/11; BFA29A, Exp 10/06/11; BFD49A, Exp 02/22/12, 04/04/12, 05/05/12; BFD57A,Exp 04/28/12; BFB51A, Exp 01/03/12;
 
149) Lot: BFB56A, Exp 10/11/11; BFB60A, Exp 12/08/11, 01/17/12; BFD46A, Exp 03/07/12; BFD47A, Exp 02/03/12, 03/13/12; C100741, Exp 11/05/11, 11/19/11, 12/06/11; C100807, Exp 01/04/12, 01/25/12, 01/26/12; C101237, Exp 03/20/12; C101577, Exp 05/05/12, 05/10/12;
 
150) Lot: PB35510, Exp 02/15/12; PA30110, Exp 06/10/11; PA30310, Exp 01/31/12; PA30410, Exp 11/18/11; PA30710, Exp 03/21/12; PA30111, Exp 05/04/12, 05/19/12; PA30810, Exp 04/11/12, 04/12/12, 04/14/12, 05/11/12, 05/15/12;
 
151) Lot: PB35910, Exp 05/19/12;
 
152) Lot: 30210373A, Exp 01/31/12;
 
153) Lot: 0171061, Exp 01/11/12;
 
154) Lot: E010190, Exp 01/31/12; G000309, Exp 03/31/12;
155) Lot: E005749, Exp 06/22/11; G001133, Exp 05/09/12;
 
156) Lot: E007880, Exp 11/10/11; E008577, Exp 11/24/11; G001057, Exp 03/29/12; G002030, Exp 04/13/12;
 
157) Lot: E009243, Exp 01/11/12;
 
158) Lot: 2042817, Exp 10/07/11; 2043705, Exp 01/07/12;
 
159) Lot: 3054FJ712, Exp 06/30/11; 3624GK712, Exp 01/31/12; 4279HK712B, Exp 02/25/12; 4279HK713B, Exp 02/11/12; 4818IK712, Exp 03/06/12, 03/16/12; 5065JJ712, Exp 07/23/11; 5765KJ712, Exp 09/15/11; 5770KJ412, Exp 09/30/11; 5770KJ712, Exp 09/07/11, 10/11/11; 6516LK712, Exp 04/04/12, 04/13/12, 04/25/12; 6898LK712A, Exp 05/05/12;
 
160) Lot: 102120, Exp 09/20/11, 11/11/11, 11/19/11, 12/22/11, 01/25/12, 03/09/12; 104066, Exp 03/09/12, 04/25/12, 05/19/12; 24558802, Exp 06/15/11, 07/06/11, 07/30/11; 9JB67, Exp 06/02/11;
 
161) Lot: 33078, Exp 11/16/11; 29311903, Exp 05/11/12; 33078, Exp 02/03/12; 33079, Exp 02/03/12;
 
162) Lot: 121191B, Exp 04/30/12;
 
163) Lot: F06200, Exp 03/31/12;
 
164) Lot: 606547, Exp 01/07/12;
 
165) Lot: 6230A, Exp 05/04/12;
 
166) Lot: 05310150, Exp 12/02/11; 0361 0190, Exp 01/11/12, 02/17/12; 1141-0140, Exp 08/19/11;
 
167) Lot: 608041, Exp 05/03/12; 5972A, Exp 04/06/12; 6099B, Exp 03/16/12; 6133B, Exp 01/19/12; 6193A, Exp 02/18/12, 03/06/12, 03/14/12, 04/07/12;
 
168) Lot: 103184, Exp 02/29/12; 104021, Exp 03/21/12, 04/19/12; 103206, Exp 05/18/12;
 
169) Lot: X100373A, Exp 03/01/12;
 
170) Lot: J08022, Exp 12/15/11, 02/08/12;
 
171) Lot: 30697, Exp 08/05/11, 08/18/11; 31843, Exp 06/30/11; 31844, Exp 06/10/11; 33031, Exp 08/18/11; 33032, Exp 09/17/11, 10/11/11, 10/22/11, 11/11/11, 11/24/11; 33435, Exp 02/04/12, 03/03/12; 33653, Exp 03/17/12;
 
172) Lot: 1151 0140, Exp 08/25/11; 0461 0130, Exp 02/14/12;
 
173) Lot: E07065, Exp 10/31/11; E47329, Exp 08/06/11; E55023, Exp 10/26/11, 11/19/11; E78931, Exp 02/29/12; 102664, Exp 02/04/12; 103430, Exp 03/20/12, 05/16/12; 103181, Exp 02/29/12; 94312, Exp 08/06/11; 101532, Exp 02/14/12; '94312, Exp 10/25/11; 531A01, Exp 05/18/12;
 
174) Lot: 605422, Exp 11/17/11, 12/01/11, 12/03/11, 12/14/11, 12/20/11, 12/21/11; 606301, Exp 11/30/11, 12/08/11, 12/09/11, 12/15/11, 12/17/11, 01/13/12; 607156, Exp 11/17/11; 600979, Exp 05/31/11; 604100, Exp 06/22/11, 06/25/11, 07/13/11, 07/16/11, 07/30/11, 02/24/12; 604976, Exp 07/02/11, 01/17/12; 605422, Exp 08/12/11, 08/24/11, 08/25/11, 08/27/11, 09/15/11, 09/28/11, 10/29/11, 01/04/12, 01/13/12, 02/11/12, 02/14/12, 02/24/12, 03/01/12, 03/03/12, 03/14/12; 605425, Exp 10/15/11, 10/29/11, 11/04/11, 01/17/12; 606301, Exp 10/29/11; 607156, Exp 12/28/11, 01/13/12, 01/26/12; 607948, Exp 02/11/12, 02/28/12, 03/01/12, 03/10/12, 03/22/12, 03/24/12, 03/29/12, 03/31/12, 04/06/12, 04/12/12, 04/14/12, 05/12/12; 608774, Exp 04/13/12, 04/17/12, 05/01/12, 05/11/12, 05/19/12; 604539A, Exp 02/29/12;
 
175) Lot: M1036, Exp 06/09/11; M1037, Exp 06/09/11, 06/23/11; M1037B01, Exp 07/08/11; M1038, Exp 08/04/11; M1038B01, Exp 07/08/11; M1045, Exp 09/23/11, 09/30/11, 10/06/11; M1045B01, Exp 08/27/11; M1045B02, Exp 10/08/11, 10/13/11; M1046, Exp 10/25/11, 11/10/11, 12/06/11, 12/10/11; M1050, Exp 12/30/11, 01/04/12; M1051, Exp 01/18/12; M1052, Exp 02/02/12, 02/14/12, 02/16/12, 03/01/12; M1052B01, Exp 03/14/12; M1054, Exp 03/28/12, 04/06/12, 04/11/12; M1054B01, Exp 04/24/12, 04/25/12; M1055, Exp 05/10/12; M1055B01, Exp 05/01/12; M1055B03, Exp 05/19/12; M1041, Exp 09/30/11; M1043, Exp 09/30/11; M1047, Exp 12/27/11; M1048, Exp 12/27/11; M1049, Exp 12/27/11; BM6393, Exp 05/19/12;
 
176) Lot: M1010, Exp 09/30/11; M1016, Exp 12/27/11; U1227, Exp 09/30/11; M1024, Exp 04/27/12; M1024B01, Exp 04/28/12;
 
177) Lot: F0179, Exp 10/28/11; F0182, Exp 10/28/11; F0193, Exp 01/26/12; F0206, Exp 03/22/12; F0209, Exp 04/28/12; F0211, Exp 03/29/12;
 
178) Lot: F0058, Exp 10/28/11; F0065, Exp 01/26/12;
 
179) Lot: 341287, Exp 02/08/12; 341335, Exp 03/01/12 
RECALLING FIRM/MANUFACTURER
Aidapak Services, LLC, Vancouver, WA, by letters on May 27, 2011, May 28/11 and May 31, 2011 and by Press Release on June 1, 2011. FDA initiated recall is ongoing.
REASON
Penicillin Cross Contamination; There is potential for beta-lactam cross contamination of non-penicillin drug products repackaged in the same facility.
VOLUME OF PRODUCT IN COMMERCE
444,936 tablets, capsules, cups, syringes, lozenges, dose packs
DISTRIBUTION
AK, CA, OR, NV, WA
__________________________________
PRODUCT
Amoxicillin for Oral Suspension, USP, 125 mg per 5ml, 80 mL (when mixed) bottle, Rx only; NDC 0093-4150-79. Recall # D-712-2012
CODE
Lot #: 35411254A, 35411255A, 35411256A, 35411257A, Exp 11/11; 35412446A, 35412447A, 35412448A, Exp 02/12; 35413485A, 35413486A, 35413487A, 35413488A, Exp 04/12; 35413918A, 35413919A, 35413920A, 35413921A, 35413922A, Exp 05/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on October 5, 2011. 
Manufacturer: Teva Canada Limited, Markham, Canada. Firm initiated recall is ongoing.
REASON
Subpotent (Single Ingredient) Drug: Product may not meet specification for potency.
VOLUME OF PRODUCT IN COMMERCE
151,772 bottles
DISTRIBUTION
Nationwide and Puerto Rico
__________________________________
PRODUCT
1) Amoxicillin 250 mg capsules, packaged in bottles, Generic for Amoxil 250 mg capsule, Rx only. Recall # D-714-2012;
 
2) Amoxicillin 500 mg capsules, Rx only, packaged in bottles and unit-dose punch cards, Rx only. Recall # D-715-2012;
 
3) Cephalexin 500 mg capsules, Rx only, packaged into bottles, dose strips, and dose punch cards. Recall # D-716-2012;
 
4) Penicillin V K 500 mg tablets, Rx only, Generic for Pen-Vee K 500 mg tablets, 40-count bottles. Recall # D-717-2012;
 
5) Amox;icillin/Clavulanate K 875/125 mg tablets, packaged in bottles and unit-dose strips, Rx only, Generic for Augmentin 875/125 mg tablets. Recall #D-718-2012
CODE
1) Code numbers: 144779, 144777
 
2) Code numbers: AH054, 1855052, AMUCB8018, 35405760A, 144893, 9BP619, AMUCB9033, AMUCB9026, AMUCB9040, AM5009030 and AM5009034-A;
 
3) Code numbers: CCA8016A, 1838115, 30300830A, CCA8017A, 2878, ULXCA9044, ULXCA9065, ULXCA9078, 1858633, 74564, CCB8068A, 2828, 30300558A, 1873331, 2698, 30300912A, 30300697A, 30300916A, ULXCB9002, 30300927A, ULXCB9046, ULXCB9047, 30301234A, ULXCB9077, 30301232A, ULXCB9073, ULXCB9098;.
 
4) Code numbers: 7RD966 and 8MD997;
 
5) Code numbers: 1868565, 35409636A, 35412325A and 35412892A
RECALLING FIRM/MANUFACTURER
Terry Yon & Associates, Inc./dba Tya Pharmaceuticals, Tallahassee, FL, by telephone on November 23, 2009. FDA initiated recall is ongoing.
REASON
Penicillin Cross Contamination: The possibility of cross-contamination between non-penicillin beta-lactam products and penicillin drug products exists.
VOLUME OF PRODUCT IN COMMERCE
55,080 tablets and capsules
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
Levothyroxine sodium tablets, USP, 137 mcg (0.137 mg), 1000-count tablets per bottle, Rx only, NDC 0527-1638-10, UPC 3 0527-1638-10 6. Recall # D-811-2012
CODE
Lot #: 013911, Exp 12/12
RECALLING FIRM/MANUFACTURER
Jerome Stevens Pharmaceuticals, Inc., Bohemia, NY, by letters on October 6, 2011 and letters dated October 14, 2011. Firm initiated recall is on going. 
REASON
Subpotent (Single Ingredient) Drug: Out-Of-Specification results were obtained during routine stability testing at the 3-month interval.
VOLUME OF PRODUCT IN COMMERCE
235 bottles
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
Wound Pack - Ortho Kit, Reorder No. 200-1066, containing 10-count packs of PVP Swabsticks 3/Pack, labeled as Povidone-Iodine Swabstick, Povidone Iodine, USP, 10%, Cat. No. 10-4102, NDC 50730-4102-3, in addition to other items not listed, Home Healthcare Solutions. Recall # D-815-2012
CODE
Lot #: 05262010, 08312010, 12142010, 03082011, Exp 03/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Safety-Med Products, Inc., Burlington, WI, by letter dated October 5, 2011. 
Manufacturer: H & P Industries, Inc., Hartland, WI. Firm initiated recall is complete.
REASON
CGMP Deviations: This kit is being recalled because a component, povidone iodine swabstick, was recalled by the manufacturer because they were manufactured without having in place a system for microbial testing at the time of release, without having a system for testing of incoming components, and without having procedures designed and established to prevent objectionable microorganisms in drug products.
VOLUME OF PRODUCT IN COMMERCE
200 kits
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
1) DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP, 120 mg/30 mL (4 mg/ mL), 30 mL Multiple Dose Vial, packaged in 25 x 30 mL Multiple Dose Vials per carton, Rx Only, NDC 0517-4930-25. Recall # D-839-2012;
 
2) DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP, 4 mg/mL, 1 mL Single Dose Vial, packaged in 25 x 1 mL Single Dose Vials per carton, Rx Only, NDC 0517-4901-25. Recall # D-840-2012;
 
3) DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP, 20 mg/5 mL (4 mg/mL), 5 mL Multiple Dose Vial, packaged in 25 x 5 mL Multiple Dose Vials per carton. Recall # D-841-2012
CODE
1) Lot #: 8811, Exp 12/10; 9093, Exp 02/11; 9195, Exp 03/11; 9296, Exp 04/11; 9419, Exp 06/11; 9505, Exp 07/11; 9649, Exp 09/11; Expansion Lot #: 0213, Exp 03/11; 0306, Exp 05/11; 0387, Exp 06/11; 0565, Exp 08/11; 0679, Exp 10/11; 0771, Exp 11/11; 0840, Exp 12/11;
 
2) Expansion Lot #: 9153, 9170, 9182, 9218, 0135, 0138, 0164, 0215, Exp 03/11; 9254, 9295, 0229, 0245, 0271, 0277, 0282, 0296, Exp 04/11; 9329, 9352, 9368, 0302, 0305, 0324, 0331, 0342, Exp 05/11; 9385, 9422, 9425, 9441, 0409, 0444, Exp 06/11; 9512, Exp 07/11; 9549, 9565, Exp 08/11; 9605, 9615, 9615A, 9656, 9668, 0593, 0599, 0639, Exp 09/11; 9690, 9710, 9722, 9743, 0678, 0710, 0736, Exp 10/11; 0773, 0792, 0803, 0819, Exp 11/11; 0836, 0846, 0853, 0879, Exp 12/11;
 
3) Expansion Lot #: 9210, 0157, 0217, Exp 03/11; 9250, 0269, Exp 04/11; 9335, 9393, 0317, Exp 05/11; 9417, 0392, 0404, 0407, Exp 06/11; 9516, 9571, 0556, Exp 08/11; 9620, 9667, 0624, Exp 09/11; 0704, Exp 10/11; 0765, 0805, Exp 11/11; 0878, Exp 12/11; 1055, Exp 01/12
RECALLING FIRM/MANUFACTURER
Luitpold Pharmaceuticals, Inc., Shirley,  NY, by letters on December 20, 2010 and by press release and letters on March 16, 2011. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter: The firm initiated a recall of several lots of Dexamethasone Sodium Phosphate Injection, USP because some vials either contain particulates or have the potential to form particulates, identified as glass particles contributed to delamination, prior to their respective expiration dates.
VOLUME OF PRODUCT IN COMMERCE
14,209,875 vials
DISTRIBUTION
Nationwide, Puerto Rico, Guam, and United Arab Emirates
___________________________________
PRODUCT
Amoxicillin Tablets, USP (Chewable) 250 mg, a) 100 count bottle (NDC 0093-2268-01) and b) 500 count bottle (NDC 0093-2268-05). Recall # D-842-2012
CODE
a) Lot # 35417130A, and b) Lot # 35417130B
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on October 19, 2011.  
Manufacturer: Teva Canada Limited, Markham, Canada. Firm initiated recall is ongoing.
REASON
CGMP Deviations: Firm's laboratory investigation was not performed in accordance with strict adherence to the "FDA Guidance for Industry - Investigating Out-of-Specification Test Results for Pharmaceutical Production"
VOLUME OF PRODUCT IN COMMERCE
5,751 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Nitroglycerin Transdermal Systems, 0.2 mg/hr. Transdermal patches, NDC 49730-111-30. Recall # D-844-2012;
 
2) Nitroglycerin Transdermal Systems, 0.4 mg/hr. Transdermal patches, NDC 49730-112-30. Recall # D-845-2012;
 
3) Nitroglycerin Transdermal Systems, 0.6 mg/hr. Transdermal patches, NDC 49730-113-30. Recall # D-846-2012;
 
4) Nitroglycerin Transdermal Systems, 0.6 mg/hr. Transdermal patches, Rx only, NDC 09045-497-46. Recall # D-847-2012;
 
5) Nitroglycerin Transdermal Systems, 0.4 mg/hr. Transdermal patches, Rx only,  NDC 09045-496-46. Recall # D-848-2012;
 
6) Nitroglycerin Transdermal Systems, 0.2 mg/hr. Transdermal patches, Rx only,NDC 09045-495-46. Recall # D-849-2012
CODE
1) Lot numbers 999044, exp 5/2012; 999049, exp 06/2012; 999051, exp 6/2012; 999053, exp 6/2012; 999055, exp 6/2012; 999059, exp 7/2012; 999062, exp 8/2012; 999069, exp 9/2012; 999071, exp 9/2012; 999074, exp 10/2012; 999078, exp 10/2012;
 
2) Lot numbers 999041, exp 5/2012; 999042, exp 5/2012; 999065, exp 8/2012; 999076, exp 10/2012;
 
3) Lot numbers 999041, exp 5/2012; 999042, exp 5/2012; 999065, exp 8/2012; 999076, exp 10/2012;
 
4) Lot 999045, exp 5/2012;
 
5) Lot 999048, exp 6/2012; 999054, exp 6/2012; 999058, exp 7/2012;
 
6) Lot 999047, exp 5/2012; 999066, exp 8/2012
RECALLING FIRM/MANUFACTURER
Hercon Laboratories Corp., Emigsville, PA, 
REASON
Miscalibrated and/or defective delivery system; Transdermal patches may fail to adhere.
VOLUME OF PRODUCT IN COMMERCE
6,790,410 boxes
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Adagen (pegademase bovine) injection, 250 units/mL, 1.5 mL single-dose vials, 4-count 1.5 mL vials per carton, Rx only, NDC 57665-001-01. Recall # D-853-2012
CODE
Lot#: 1007A, Exp 25/FEB/201
RECALLING FIRM/MANUFACTURER
Sigma-Tau Pharmasource, Inc., Indianapolis, IN, by letters on October 26, 2011. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: During routine stability testing, levels of Impurity C were out of specification. 
VOLUME OF PRODUCT IN COMMERCE
249 cartons
DISTRIBUTION
Nationwide, France, and South Australia
___________________________________
PRODUCT
1) Tazicef Ceftazidime for Injection, USP, 1 gram single-dose ADD-Vantage 21 mL Vial for use only with ADD-Vantage diluent container, 25 vials per carton, 4 cartons per case; a third generation cephalosporin antibiotic; a) NDC 0409-5092-16 (Hospira label); b) NDC 0409-5092-52 (Novoplus label). Recall # D-861-2012;
 
2) Tazicef Ceftazidime for Injection, USP, 2 gram single-dose ADD-Vantage 21 mL Vial for use only with ADD-Vantage diluent container, 10 vials per carton, 4 cartons per case; a third generation cephalosporin antibiotic; a) NDC 0409-5093-11 (Hospira label), b) NDC 04009-5093-51 (Novoplus label). Recall # D-862-2012
CODE
1) a) Lot numbers 860158M, exp 2/1/2012; 860168M, exp 2/1/2012; 860178M, exp 2/1/2012; 890288M, exp 5/1/2012; 890298M, exp 5/1/2012; 920098M, exp 8/1/2012; 940068M, exp 10/1/2012; 960018M, exp 12/1/2012; 020098M, exp. 2/1/2013; 020108M, exp. 2/1/2013; and 030368M, exp 3/1/2013; b) lot numbers 860148M, exp 2/1/2012; 860158M, exp 2/1/2012; 890298M, exp 5/1/2012; 920088M, exp 8/1/2012; 920098M, exp 8/1/2012; 940068M, exp 10/1/2012; 960018M, exp 12/1/2012; 020098M, exp. 2/1/2013; and 030368M, exp 3/1/2013;
 
2) a) Lot numbers 820298M, exp 10/1/2011; 820308M, exp 10/1/2011; 860188M, exp 2/1/2012; 860198M, exp 2/1/2012; 860208M, exp 2/1/2012; 860218M, exp 2/1/2012; 890268M, exp 5/1/2012; 890278M, exp 5/1/2012; 920118M, exp 8/1/2912; 920128M, exp 8/1/2912; 940078M, exp 10/1/2012; 960028M, exp 12/1/2012; 960038M, exp 12/1/2012; 020118M, exp 2/1/2013; 020128M, exp 2/1/2013; and 030378M, exp 3/1/2013; b) lot numbers 860188M, exp 2/1/2012; 890278M, exp 5/1/2012; 920108M, exp 8/1/2912; 920118M, exp 8/1/2912; 960038M, exp 12/1/2012; and 020118M, exp 2/1/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, by letters dated September 30, 2011.
Manufacturer: Sandoz GmbH, Kundl, Austria. Firm initiated recall is ongoing.
REASON
CGMP Deviations; out-of-specification for one or more of the following attributes during routine stability testing: sub-visible particulate, related substances, pyridine and assay.
VOLUME OF PRODUCT IN COMMERCE
562,025 vials
DISTRIBUTION
Nationwide including Guam
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
1) Ropinirole Hydrochloride Tablets, 0.25 mg, 100-count tablets per bottle, Rx only, NDC 64720-201-10. Recall # D-807-2012;
 
2) Ropinirole Hydrochloride Tablets, 0.5 mg, 100-count tablets per bottle, Rx only, NDC 64720-202-10. Recall # D-808-2012;
 
3) Ropinirole Hydrochloride Tablets, 1 mg, 100-count tablets per bottle, Rx only, NDC 64720-203-10. Recall # D-809-2012;
 
4) Ropinirole Hydrochloride Tablets, 2 mg, 100-count tablets per bottle, Rx Only, NDC 64720-204-10. Recall # D-810-2012
CODE
1) Lot #: 102232, Exp 03/11; 102794, 102795, Exp 05/11; 103611, 103612, Exp 07/11; 104441, Exp 10/11; 104876, Exp 01/12; 105557, 105558, Exp 03/12;
 
2) Lot #: 100364, Exp 03/11; 101184, Exp 05/11; 101310, 101311, Exp 06/11; 101649, Exp 07/11; 101865, Exp 08/11; 102239, Exp 09/11; 102793, Exp 11/11; 103537, Exp 01/12; 103989, Exp 03/12; 105027, Exp 06/12; 105202, Exp 07/12; 105559, 105560, Exp 09/12;
 
3) Lot #: 100849, 100897, Exp 04/11; 101182, 101183, Exp 05/11; 101341, Exp 06/11; 101787, Exp 07/11; 102119, 102120, Exp 09/11; 102458, 102459, Exp 10/11; 102961, 102962, Exp 12/11; 103668, 104442, Exp 04/12; 104878, 104879, Exp 07/12; 105514, 105515, Exp 09/12;
 
4) Lot #: 100838, Exp 04/11; 101280, Exp 06/11; 101650, Exp 07/11; 101922, 101923, Exp 08/11; 102796, Exp 11/11; 103613, Exp 01/12; 104067, Exp 04/12; 104623, Exp 05/12; 105518, 105519, Exp 09/12
RECALLING FIRM/MANUFACTURER
Corepharma L, Middlesex, NJ, by letters dated April 1, 2011. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: Ropinirole Hydrochloride Tablets may not meet the specification for a known impurity over the product shelf life.
VOLUME OF PRODUCT IN COMMERCE
1,103,813 bottles
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Walgreens Children's Triple Acting Daytime Cold & Cough, 4 oz., batch # 213836, 215792, 215770, 215771. Recall # D-814-2012
CODE
Lot numbers: 50236, 50244, 50259, 50260
RECALLING FIRM/MANUFACTURER
Aaron Industries Inc, Lynwood, CA, by letter dated October 5, 2010. Firm initiated recall is ongoing. 
REASON
Labeling: Label mix-up; Product has a discrepancy for the indications on the Principal Display Panel for the unit carton.
VOLUME OF PRODUCT IN COMMERCE
62,064 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
The Magic Bullet (bisacodyl) suppository, 10 mg, a) 12-count suppositories per carton, NDC 57648-002-12; b) 100-count suppositories per carton, NDC 57648-002-01. Recall # D-858-2012
CODE
Lot #: a) 10101, Exp 07/11; 10201, Exp 08/11; 10306, Exp 09/11; 10504, Exp 11/11; 10703, Exp 01/12; b) 10101, 10106, Exp 07/11; 10201, Exp 08/11; 10305, 10306, Exp 09/11; 10403, Exp 10/11; 10504, Exp 11/11; 10602, Exp 12/11; 10703, Exp 01/12
RECALLING FIRM/MANUFACTURER
Elge, Inc., Rosenberg, TX, by letters dated July 26, 2011. Firm initiated recall is ongoing.
REASON
Subpotent (Single Ingredient) Drug: The product may not maintain its labeled potency throughout its expiration date.
VOLUME OF PRODUCT IN COMMERCE
20,254 cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Ovcon 50 (Norethindrone and Ethinyl Estradiol, Tablets, USP) (trade 3 x 28''s); a) NDC 0430-0585-45; and (Sample 6 x 28's), b) NDC 0430-0585-95; Rx only. Recall # D-863-2012
CODE
a) Lot #01150F; b) Lot 01150FA
RECALLING FIRM/MANUFACTURER
Recalling Firm: Warner Chilcott Inc., Rockaway, NJ, by letters on July 7, 2011. 
Manufacturer: Warner Chilcott Company LLC, Fajardo, PR. Firm initiated recall is ongoing.
REASON
Subpotent; 12 month time point for ethinyl estradiol.
VOLUME OF PRODUCT IN COMMERCE
21,211 units (trade 3x28); 2,243 units (Physician Samples 6x28)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Red Hot Ointment (Oleoresin Capsicum), 4.95%, a) 2.75 ounces (78 g) tube, UPC 3 11960 04644 2, Stock No. 180522; b) 1 Lb (454 g) jar, UPC 3 11960 04614 5, Stock No. 180538. Recall # D-865-2012
CODE
Lot #: LVC138, Exp 04/06/13
RECALLING FIRM/MANUFACTURER
Cramer Products Inc., Gardner, KS, by letter on June 6, 2011. Firm initiated recall is ongoing.
REASON
Subpotent (Single Ingredient) Drug: The firm found low potency test results on stability samples of Red Hot Analgesic Ointment.
VOLUME OF PRODUCT IN COMMERCE
1,211 tubes and 564 jars
DISTRIBUTION
Nationwide, Puerto Rico, Guam, Bermuda, Canada, Mexico, and Spain
___________________________________
PRODUCT
Potassium Citrate Tablets, 540 mg (5 mEq per tablet), 100-count tablets per bottle, Rx Only, UPC 3 0245-0070-11 5. Recall # D-867-2012
CODE
Lot # 1A013, Exp 12/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Upsher Smith Laboratories, Inc., Maple Grove, MN, by letters, dated November 14, 2011.
Manufacturer: Mission Pharmacal Co. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Test Requirements: Upsher-Smith Laboratories is recalling one lot of Potassium Citrate Tablets because the product failed to meet specifications for dissolution at the 9-month test point on stability.
VOLUME OF PRODUCT IN COMMERCE
18,697 bottles
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0080-12
CODE
Unit: FN05026
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone and facsimile on December 26, 2006. Firm initiated recall is complete.
REASON
Platelet, which had an unacceptable platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-0081-12
CODE
Unit: 0610012622
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Parkersburg, WV, by letter on March 28, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had been incarcerated, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Spain
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0082-12
CODE
Unit: LS13655
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Sacramento, CA, by telephone and facsimile on April 9, 2008. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall #B-0083-12
CODE
Unit: LS13654
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Sacramento, CA, by telephone on April 9, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-0084-12
CODE
Units: 08MOHH3947; 08MOHH4597; 08MOHH6256; 08MOHH9934; 08MOHI0645; 08MOHI2970; 08MOHI4081;08MOHI5298; 08MOHJ1517; 08MOHJ5217; 08MOHJ3726; 08MOHJ2976; 09MOHA5995; 09MOHA5197; 09MOHA3808; 09MOHA2955; 09MOHA1546; 09MOHA0699; 08MOHK6185;08MOHK5360; 08MOHK4489; 08MOHK3726; 08MOHK2273; 08MOHK1448; 08MOHJ9877; 08MOHJ9032; 08MOHJ6140
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Lima, OH, by facsimile on April 23, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0086-12
CODE
Unit: LM41640
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on July 5, 2006. Firm initiated recall is complete
REASON
Blood product, which was labeled as leukoreduced, but did not meet the requirements for a leukoreduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0104-12
CODE
Unit: 9607196
RECALLING FIRM/MANUFACTURER
Northern California Community Blood Bank, Eureka, CA, by facsimile on March 22, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced. Recall # B-0106-12;
2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0107-12;
3) Red Blood Cells Leukocytes Reduced. Recall # B-0108-12
CODE
1) Unit: 084C35414 (part 1), 084C35759 (part 1);
2) Unit: 084C35759 (part 2);
3) Unit: 084T05493
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by facsimile on May 10, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Recall # B-0145-12
CODE
Unit: W0410100529538
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc dba United Blood Services, Scottsdale, AZ, by telephone and fax on August 15, 2011. Firm initiated recall is complete.
REASON
Blood product, incorrectly determined to be negative for the Fy(b) antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0146-12
CODE
Unit: W041010062772N
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc dba United Blood Services, Scottsdale, AZ, by telephone and fax on September 26, 2011. Firm initiated recall is complete.
REASON
Blood product, incorrectly determined to be negative for the Jk(b) antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0147-12
CODE
Unit: 53FC04554
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by letter dated August 13, 2011. Firm initiated recall is complete.
REASON
Blood product, incorrectly identified as negative for the e antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0148-12
CODE
Unit: W0423110397884
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Billings, MT, by telephone and fax on August 17, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received a body piercing within 12 months of donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE
MT
DISTRIBUTION
1 unit
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0149-12;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-0150-12
CODE
1) and 2) Unit: W037911891130
RECALLING FIRM/MANUFACTURER
LifeServe Blood Center, Des Moines, IA, by telephone on August 25, 2011. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC, NB
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0151-12
CODE
Units: W037911145342; W037911147678; W037911147559; W037911142216
RECALLING FIRM/MANUFACTURER
LifeServe Blood Center, Des Moines, IA, by telephone on August 25, 2011. Firm initiated recall is complete.
REASON
Blood products, leukoreduced more than 72 hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NC, IA
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0157-12;
2) Fresh Frozen Plasma. Recall # B-0158-12;
3) Red Blood Cells Leukocytes Reduced. Recall # B-0159-12
CODE
1) Unit: LM42476;
2) Unit: LM42470;
3) Units: LM42445; LM42449; LM42450; LM42456; LM42461; LM42466; LM42470; LM42475; LM42477
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on November 10, 2006 and fax on November 13 and 15, 2006. Firm initiated recall is complete.
REASON
Blood products, possibly contaminated with air during collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0205-12
CODE
Unit: W038111265847
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by letter dated August 31, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area possibly endemic for malarial, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0206-12
CODE
Units: W142811095152; W142811095152; W142811095152
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tri-counties Blood Bank, San Luis Obispo, CA, by telephone on September 2, 2011.
Manufacturer: Tri-counties Blood Bank Dba Ubs Central Coast, Ventura, CA. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0207-12
CODE
Unit: W037911891639
RECALLING FIRM/MANUFACTURER
LifeServe Blood Center, Des Moines, IA, by letter dated October 6, 2011. Firm initiated recall is complete.
REASON
Blood product, labeled leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0223-12
CODE
Unit: W141607512157
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by e-mail on September 12, 2007.
Manufacturer: Puget Sound Blood Center and Program, Bellingham, WA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-0224-12
CODE
Units: 0060077409, 0060077503, 0060078092, 0060078204, 0060078656, 0090078928, 0060079184, 0060079389, 0060079914, 0060080166, 0060080420, 0060080746, 0060080920, 0060081187, 0060081385, 0060081701, 0060081900, 0060082183, 0060082397, 0060082689, 0060082818, 0060083256, 0060083458, 0060084000, 0060084375, 0060084670, 0060084940, 0060085256, 0060086116, 0060086302, 0060099576
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Boise, IA, by fax on June 26. 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for vCJD risk, were distributed.
VOLUME OF PRODUCT IN COMMERCE
31 units
DISTRIBUTION
CA, Spain
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-0225-12; 
2) Red Blood Cells Leukocytes Reduced. Recall # B-0226-12;
3) Recovered Plasma. Recall # B-0227-12
CODE
1) and 2) Units: 0930975; 0929530; 0928140;
3) Unit: 5313396
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by fax and letter on August 16, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor receiving Lupron injections, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
WA, ID, Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-0228-12
CODE
Units: 3270009618, 3270009390, 3270008483, 3270007972, 3270007678, 3270007145, 3270006916, 3270006109, 3270005501, 3270005245, 3270004623, 3270004467, 3270003925, 3270003510, 3270003061, 3270002725, 3270002493, 3270002200, 3270002031, 3270001806, 3270001636, 3270000339, 3270000219, 3270000146
RECALLING FIRM/MANUFACTURER
Recalling Firm: Talecris Plasma Resources, Inc., Research Triangle Park, NC, by fax on December 18, 2008.
Manufacturer: Talecris Plasma Resources, Inc., Indianapolis, IN. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a body piercing within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
NC
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Cryoprecipitated AHF. Recall # B-0085-12
CODE
Unit: LQ07704
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on February 6, 2007. Firm initiated recall is complete.
REASON
Blood product, not manufactured in accordance to current Good Manufacturing Practices, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0087-12;
 
2) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0088-12
CODE
1) GF75993; GF75966; GF75994; LG34805; LH77420; GF76005; LH84559; GF66867; LH84557; LH86318;
 
2) Units: LH75541; LH84268
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on August 4, 2006. Firm initiated recall is complete.
REASON
Blood products, which may have reached unacceptable temperatures during storage, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0176-12
CODE
Unit: 2576895
RECALLING FIRM/MANUFACTURER
Northern California Community Blood Bank, Eureka, CA, , by facsimile and phone on February 8, 2007. Firm initiated recall is complete.
REASON
Blood product, to which the component preparation staff member failed to add the appropriate amount of additive (OPTISOL) to the Red Blood Cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0208-12
CODE
Unit: W012110006246
RECALLING FIRM/MANUFACTURER
Department of the Army, Tripler Army Medical Center, Hawaii, by letter dated May 11, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
___________________________________
PRODUCT
Bioplate Titanium Fixation System, Sterile Kit. The sterile plate and screw kit configurations for use with the Bioplate Titanium Fixation System are intended for use on non-load bearing fixation, including cranial bone fixation and brow fixation and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implant. Recall # Z-0143-2012
CODE
Product Code Lot # 81-2093 G03411108 G03680409 81-2094 G03421108 G03690409 81-3573 1000 1002 1527 G03251108 G03630409 G03920709 81-3574 G03391108 G03650409 81-3575 1004 1543 G03261108 G03431208 G03660409 G03740509 G03880709 81-3576 1244 1561 G03221108 G03670409 81-3577 G03231108 G03640409 G03820609 G03890709 81-3578 1075 1690 G03241108 G03830609 81-3579 1167 1562 G03401108 G03450109 81-3580 185 G03211108 G03460109 G03590309 G03840609 81-3581 414 1034 1524 1894 G03201108 G03600309 G03750509 G03870609 G03900709 81-3582 993 1220 1692 G03331108 G03770509 G03910709 81-3583 G03271108 G03790509 81-3584 G03341108 G03850609 81-3585 G03351108 G03610309 81-3586 1005 G03371108 81-3587 G03361108 81-3588 1812 G03381108 G03860609 81-3590 G03311108 G03440109 G03550209 81-3591 1637 1816 G03321108 G03480109 G03560209 G03620309 81-3592 1069 G03490109 G03570209 G03780509 81-3593 1070 G03470109 81-5888 1813 81-5890 1043 81-5894 G03281108 81-5895 1023 1227 1240 1817 G03291108 81-5896 G03301108 81-5900 1814 G03700409 81-5901 G03710409 81-5902 G03720409 81-5903 1818 G03730409 G03760509
RECALLING FIRM/MANUFACTURER
Bioplate Inc., Los Angeles, CA, by letter dated March 18, 2010. Firm initiated recall is ongoing.
REASON
There is potential defect in seal of the sterile barrier containing the device.
VOLUME OF PRODUCT IN COMMERCE
2, 226 boxes; 16,020 individual kits.
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) RSP Humeral Socket Reamer (Size 32 SML): DJO Surgical Instruments and Instrument Cases DJO surgical. The product is intended to be used to ream prepare the humeral bone for accepting the implant. It has a spring loaded alignment pin on the proximal (reaming) end used in both alignment of the reamer and as an indication that the reamer has been seated fully. DJO Surgical Part Number 804-02-013, 804-02-014, and 804-02-015.
Recall # Z-0150-2012;
 
2) RSP Baseplate Rim Planer (Size 32, 36, 40): DJO Surgical Instruments and Instrument Cases DJO surgical. The Baseplate Rim Planer is used to prepare the bone around the peripheral rim of the reamed socket. It has a spring loaded alignment pin on the proximal (cutting) end used in both alignment of the planer and as an indication that the planer has been seated fully. DJO Surgical Part Number 804-03-010, 804-03-034, and 804-03-035.
Recall # Z-0151-2012
CODE
All lots
RECALLING FIRM/MANUFACTURER
Encore Medical, LP, Austin, TX, by letter dated September 28, 2011. Firm initiated recall is ongoing.
REASON
The alignment pins cannot be consistently cleaned using the technique provided in the cleaning/sterilization section of the instrument IFU.
VOLUME OF PRODUCT IN COMMERCE
399 Reamers and 133 Planers
DISTRIBUTION
Nationwide, Germany, South America, Italy, Saudi Arabia, United Kingdom, and Canada
___________________________________
PRODUCT
Spectra Optia Apheresis System, REF: 61000. A blood component separator used for therapeutic plasma exchanges. Recall # Z-0191-2012
CODE
Serial Numbers: 1P00100 - 1P00XXX
RECALLING FIRM/MANUFACTURER
Caridian BCT, Inc., Lakewood, CO, by letter dated September 2011. Firm initiated recall is ongoing.
REASON
Possible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis.
VOLUME OF PRODUCT IN COMMERCE
852 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Stryker Endoscopy 3.55 MM Super 90 S-SERFAS Energy Probe; electrosurgical device. Model number: 279-351-300. Recall # Z-0265-2012
CODE
Lots 11161AE2 to 11241AE2, Lots are numbered sequentially using the middle three numbers, i.e 161-241.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Endoscopy, San Jose, CA, by letter dated October 25, 2011.
Manufacturer: Stryker, Arroyo, PR. Firm initiated recall is ongoing.
REASON
An increased number of complaints for tip breaks were observed for the 3.5mm Super 90-S SERFAS Energy Suction Probes manufactured from June to August 2011.
VOLUME OF PRODUCT IN COMMERCE
6307 probes
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
STERIS 5085 and 5085SRT Surgical Tables, Catalog Numbers: 5085- ST01-410-1; 5085SRT- ST0-1420-6. Recall # Z-0279-2012
CODE
Tables identified with the following Codes are subject to correction: 0401510077 to 0421411110. (Note: not all tables manufactured in this range are affected by this voluntary field correction).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Steris Corp. Mentor, OH, by letter on October 17, 2011.
Manufacturer: Steris Corp, Montgomery, AL. Firm initiated recall is ongoing.
REASON
Some hydraulic column cylinders installed in certain 5085 and 5085SRT Surgical Tables were assembled by their supplier with incorrect snap rings and an anomaly was present in the tilt cylinder. This error may affect the user's ability to move the table top out of the full right tilt position.
VOLUME OF PRODUCT IN COMMERCE
167 units. 5085 = 108 & 5085SRT = 59
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS I
___________________________________
PRODUCT
6" - 8" Merrick Doggie Wishbones All Natural Beef Chew For Dogs, UPC 0 22808 29050 6. Recall # V-008-2012
CODE
Lot 11031, Best By 30 Jan 2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tejas Industries Inc., Hereford, TX, by press release on August 8, 2011.
Manufacturer: Tejas Industries Inc., Plainview, TX. FDA initiated recall is ongoing.
REASON
The product has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
248 cases
DISTRIBUTION
NY, WA, KS, CA, IL, MD, RI, FL, and GA
 
RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS II
___________________________________
PRODUCT
28% Catfish Feed. Recall # V-009-2012
CODE
none, bulk product
RECALLING FIRM/MANUFACTURER
Recalling Firm: Melick Aquafeed, Catawissa, PA, by letter on 10/26/2011.
Manufacturer: Melick Aquafeed LLC, Greenville, MI. Firm initiated recall is ongoing.
REASON
Catfish feed was manufactured using corn that was found to be above the legal limit for Aflatoxin.
VOLUME OF PRODUCT IN COMMERCE
300 tons
DISTRIBUTION
TX, MO, AR
 
RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS III
___________________________________
PRODUCT
Old Label: Product labeled in part: "***ONLY NATURAL PET***IMMUNE STRENGTHENER***Immune System Support***NET CONTENTS 90 CAPSULES***PRODUCT FACTS:***N-Acetyl-Cysteine...50 mg*** " New Label: Product labeled in part: "***ONLY NATURAL PET***IMMUNE STRENGTHENER***Immune System Support***NET CONTENTS 90 CAPSULES***PRODUCT FACTS:***N-Acetyl-Cysteine...5 mg. Recall # V-010-2012
CODE
Lot numbers: 020318, 020126, and 020079
RECALLING FIRM/MANUFACTURER
Ion Labs Inc., Clearwater, FL, via telephone on April 28, 2011. Firm initiated recall is ongoing.
REASON
The Immune Strengthener labeling declares N-Acetyl Cysteine as 50 mg instead of 5 mg.
VOLUME OF PRODUCT IN COMMERCE
2,518
DISTRIBUTION
CO
 
END OF ENFORCEMENT REPORT FOR NOVEMBER 30, 2011
 
#