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U.S. Department of Health and Human Services

Safety

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Enforcement Report for October 19, 2011

 

 
October 19, 2011                                                                                        11-42
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
True Leaf Farms Chopped Romaine Lettuce, 2 # bags. Recall # F-0019-2012
CODE
Box and Bag codes B256-46438-8, Best by Date of 9/29/2011. This was distributed to retail locations - Cash and Carry Box codes B256-46427-8 and A256-43452 -8, both Best by date of 9/29/2011, are also being recalled but were sent to food service and not available to consumers. Therefore, these two codes were not included in press.
RECALLING FIRM/MANUFACTURER
True Leaf Farms, San Juan Bautista, CA, by e-mail on September 28, 2011 and press release on September 29, 2011. FDA initiated recall is ongoing.
REASON
IEH sample Positive sample for Listeria monocytogenes in chopped romaine lettuce from True Leaf Farms.
VOLUME OF PRODUCT IN COMMERCE
2498 cases, 17127 lbs
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Hard-E Foods Cantaloupe Chunk, 5 lb. tub. Recall # F-0020-2012
CODE
USE BY SEP.10.11 245, SEP.12.11 247, SEP.14.11 249, and SEP .15.11 250
RECALLING FIRM/MANUFACTURER
Hard-E Foods Inc., Saint Louis, MO, by telephone and e-mail on September 15, 2011. Firm initiated recall is complete.
REASON
The cantaloupe is potentially contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
Approximately 65/5-lb. tubs
DISTRIBUTION
MO
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
1) Individual Tuxedo Bombe. Ingredients: Sugar, Enriched wheat flour bleached, coco processed with alkali, good starch-modified, soybean oil, dry whey, leavening , vital wheat gluten, salt, carmel color, propylene glycol ester, mono & diglycerides, sodium stearoyl lactylate, dextrose, tricalcium phosphate, artificial flavor, corn starch, red 40 propylene glycol, water, wheat starch, sulfites, silicon dioxide, sodium sulfate, citric acid, eggs, oil, white mousse, whip topping heavy cream, kakolate, chocolate chips, corn syrup. Annie's Euro Bakery Individual Tuxedo Bombe. Code: (01) 1 0837793 00601 5. Recall # F-0011-2012;
 
2) Individual Raspberry Lemon Drop. Ingredients: Sugar, bleached wheat flour, soybean oil, food starch, salt, baking soda, eggs, vegetable oil, water, cocoa, cotton seed oil, shortening, fondant, vanilla, 1# Super 50, Heavy Cream, Alaskan Lemon Mousse, European Raspberry, Spun Gold, White chocolate curls. Annie's Euro Bakery Individual Raspberry Lemon Drop. Code: (01) 1 0837793 00858 9. Recall # F-0012-2012;
 
3) Individual Jack Daniels. Ingredients: Sugar, Enriched wheat flour bleached, coco processed with alkali, good starch-modified, soybean oil, dry whey, leavening , vital wheat gluten, salt, carmel color, propylene glycol ester, mono & diglycerides, sodium stearoyl lactylate, dextrose, tricalcium phosphate, artificial flavor, corn starch, red 40, propylene glycol, water, wheat starch, sulfites, silicon dioxide, sodium sulfate, citric acid. Liquid Sugar, partially hydrogenated soybean and cottonseed oils, corn syrup, cocoa, water, artificial flavor. Bourbon. Annie Pies Bakery Ind. Jack Daniels. Code: (01) 8 3779300 8605. Recall # F-0013-2012
CODE
1) Date Codes: 284, 285, 286, 287, 288, 291, 292, 293, 294, 295, 298, 299, 300, 301, 302, 305, 306, 307, 308, 309, 312, 313, 314, 315, 316, 319, 320, 321, 322, 323, 326, 327, 328, 329, 330, 333, 334, 335, 336, 337, 340, 341, 342, 343, 344, 347, 348, 349, 350, 351, 354, 355, 356, 357, 358, 361, 362, 363, 364, 365, 003, 004, 005, 006, 007, 010;
 
2) Date Codes: 284, 285, 286, 287, 288, 291, 292, 293, 294, 295, 298, 299, 300, 301, 302, 305, 306, 307, 308, 309, 312, 313, 314, 315, 316, 319, 320, 321, 322, 323, 326, 327, 328, 329, 330, 333, 334, 335, 336, 337, 340, 341, 342, 343, 344, 347, 348, 349, 350, 351, 354, 355, 356, 357, 358, 361, 362, 363, 364, 365, 003, 004, 005, 006, 007, 010;
 
3) Date Codes: 284, 285, 286, 287, 288, 291, 292, 293, 294, 295, 298, 299, 300, 301, 302, 305, 306, 307, 308, 309, 312, 313, 314, 315, 316, 319, 320, 321, 322, 323, 326, 327, 328, 329, 330, 333, 334, 335, 336, 337, 340, 341, 342, 343, 344, 347, 348, 349, 350, 351, 354, 355, 356, 357, 358,361, 362, 364, 365, 003, 004, 005, 006, 007, 010
RECALLING FIRM/MANUFACTURER
Berke-Blake Fancy Foods, Inc. dba Annie's Euro American Bake, Longwood, FL, by letter on January 31, 2011. FDA initiated recall is ongoing.
REASON
FDA inspected the firm and determined that they were baking cakes with PVC pipes, a non approved food contact utensil.
VOLUME OF PRODUCT IN COMMERCE
2,146 cases
DISTRIBUTION
Nationwide
 
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
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
CODE
All lots; UPC: 2657061476
RECALLING FIRM/MANUFACTURER
Recalling Firm: Superior Metabolic Technologies, Kennesaw, GA
Manufacturer: Chaotic Labz, Dover, AK
REASON FOR RECALL
Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug because it contains 2a 17a dimethyl etiochoian 3, one 17b-ol, also known as Superdrol (methasterone), a synthetic steroid.
_____________________________________
PRODUCT
Piperacillin and Tazobactam for Injection, a) 2.25 grams; b) 3.375 grams; c) 4.5 grams ADD-Vantage Vials For IV Use
CODE
a)950098M, 950108M, 010098M; b) 950088M, 010048M, 010068M, 010078M, 020308M, 030108M, 030118M, 040138M; c) 950028M, 950038M, 010018M, 010198M, 040108M
RECALLING FIRM/MANUFACTURER
Recalling Firm:Sandoz Inc, Princeton, NJ
Manufacturer: Sandoz GmbH Kundl, Austria
REASON FOR RECALL
 Product fails to meet established particulate count specification
_____________________________________
PRODUCT
Migergot (Ergotamine Tartrate 2 mg and Caffeine 100 mg) Suppositories
CODE
Lot #016609002 Expiration: July 2012
RECALLING FIRM/MANUFACTURER
G & W Laboratories Inc., South Plainfield, NJ
REASON FOR RECALL
Impurities/Degradation Products: Failed to meet established specification limits prior to product expiration.
______________________________________
PRODUCT
CellCept (mycophenolate mofetil) Oral Suspension, 200 mg/mL, 175 mL after constitution in a 225 mL bottle
CODE
Lot #: 896992, 896993, 904407, 904408, 905985, 905986, 905987, Exp 02/28/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Genentech Inc., South San Francisco, CA
Manufacturer: Patheon Inc. – Toronto Region Operations, Mississauga, Ontario, Canada
REASON FOR RECALL
The Press-In Bottle Adapter (PIBA) does not fit into the CellCept Oral Suspension bottles.
______________________________________
PRODUCT
Nostrilla Nasal Decongestant, 15 mL
RECALLING FIRM/MANUFACTURER
Insight Pharmaceuticals, LLC, Langhorne, PA
Ultra Seal Corporation, New Paltz, NY 
CODE
11G075, UPC Code 6373673005, Exp. Date: 36 months
REASON FOR RECALL: Microbial Contamination of Non-Sterile Product: This product is being recalled due to the presence of Burkholderia cepacia
_____________________________________
PRODUCT
Walgreens Children's Triple Acting Day Time Cold and Cough, 4 fl. oz
RECALLING FIRM/MANUFACTURER
Aaron Industries Inc. Lynwood, CA
CODE
50236, 50244, 50259 and 50260, Exp. Date: 08/2012
REASON FOR RECALL
Label: Ingredent mix-up due to mislabeling. principle display panel for the unit carton states the product relieves sneezing and runny nose symptoms, whereas the panel should state for the relief of cough and stuffy nose symptoms. The active ingredients are identified correctly on all product labeling. 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I 
___________________________________
PRODUCT
VIA XTREME ULTIMATE SEXUAL ENHANCER Dietary Supplement For Men, 6 count bottles. Recall # D-315-2012
CODE
Lots: 809013, 806030, A032111
RECALLING FIRM/MANUFACTURER
Recalling Firm: Globe All Wellness, LLC, Hollywood, FL, bypress release and e-mail on June 7, 2011.
Manufacturer: Florida Supplement, LLC, Hollywood, FL. Firm initiated recall is ongoing.
REASON
Marketed Without an Approved NDA/ANDA: Product found to contain sulfoaildenafil methanesulfonate, sulfosildenafil and dimethylsildenafil, all of which are analogues of sildenafil, the active ingredient in a FDA approved drug used to treat erectile dysfunction.
VOLUME OF PRODUCT IN COMMERCE
13,273 bottles
DISTRIBUTION
Nationwide and the Bahamas, Canada, Jamaica, and Spain
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II 
__________________________________
PRODUCT
1) GABAPENTIN, 100 MG, Caplets, NDC 16714-0661-01. Recall # D-226-2012;
 
2) GABAPENTIN, 250 MG/5 ML, Solution, NDC 00071-2012-23. Recall # D-227-2012;
 
3) GABAPENTIN, 800 MG, Tablets, NDC 62756-0204-03, 68462-0127-01. Recall #
D-228-2012;
 
4) GALANTAMINE HBR ER, 24 MG, Caplets, NDC 10147-0893-03. Recall # D-229-2012;
 
5) GALANTAMINE HBR ER, 8 MG, Caplets, NDC 10147-0891-03. Recall # D-230-2012;
 
6) GALANTAMINE HYDROBROMIDE, 4 MG, Tablets, NDC 10147-0881-06. Recall # D-231-2012;
 
7) GEMFIBROZIL, 600 MG, Tablets, NDC 00093-0670-05, 31722-0225-60. Recall # D-232-2012;
 
8) GLIMEPIRIDE, 1 MG, Tablets, NDC 00093-0221-10, 00093-7254-01.
Recall # D-233-2012;
 
9) GLIMEPIRIDE, 2MG, Tablets, NDC 00093-7255-01. Recall # D-234-2012;
 
10) GlipiZIDE ER, 2.5 MG, TABLETS, NDC 00591-0460-05; 00591-0460-10, 00781-1452-01; 00781-1452-10. Recall # D-235-2012;
 
11) GlipiZIDE 5 MG, TABLETS, NDC 00049-1620-30, 59762-5031-01. Recall # D-236-2012;  
 
12) GLUCOSAMINE SULFATE, 166.667 MG, CAPLETS, NDC 58119-0100-29. Recall # D-237-2012;
 
13) GLUCOSAMINE SULFATE, 500 MG, CAPLETS, NDC 00182-4048-26, 00904-5293-52, 40985-0225-64. Recall # D-238-2012;
 
14) GLUCOSAMINE/CHONDROITIN, 500/400MG, TABLETS, NDC 00904-5592-93. Recall # D-239-2012;
 
15) GLUCOSAMINE/CHONDROITIN DS, 500/400MG, CAPLETS, NDC 00677-1652-06, 00904-5481-52, 51991-0031-06. Recall # D-240-2012;
 
16) GlyBURIDE, 1.25 MG, TABLETS, NDC 00093-8342-01, 64720-0123-10, 65862-0028-01. Recall # D-241-2012;
 
17) GlyBURIDE, 2.5 MG, TABLETS, NDC 00093-8343-01, 64720-0124-10. Recall # D-242-2012;
 
18) GlyBURIDE, 5 MG, TABLETS, NDC 00093-8344-01, 00093-8344-05. Recall # D-243-2012;
 
19) GLYBURIDE MICRONIZED, 1.5 MG, TABLETS, NDC 67253-0460-10. Recall # D-244-2012;
 
20) GlyBURIDE MICRONIZED, 3 MG, TABLETS, NDC 67253-0461-10. Recall # D-245-2012;
 
21) GlyBURIDE_metFORMIN HCL, 2.5_500 MG, TABLETS, NDC 00093-5711-01. Recall # D-246-2012;
 
22) GLYCERIN, NDC 24385-0033-30. Recall # D-247-2012;
 
23) GLYCOPYRROLATE, 1 MG, TABLETS, NDC 55111-0648-01, 64980-0131-01. Recall #D-248-2012;
 
24) GLYCOPYRROLATE, 2 MG, TABLETS, NDC 00603-3181-21, 55111-0649-01, 64980-0132-01. Recall # D-249-2012;
 
25) GOLDEN AGE MULTIVITAMIN LIQUID, 15 ML, CUP, NDC 50383-0786-08. Recall # D-250-2012;
 
26) GRISEOFULVIN MICROSIZE, 500 MG, TABLETS, NDC 00062-0214-60. Recall # D-251-2012;
 
27) guaiFENesin, 200 MG, TABLETS, NDC 00603-4886-21, 00904-5154-60. Recall # D-252-2012;
 
28) guaiFENesin ER, 600 MG BI-LAYER, TABLETS, NDC 63824-0008-01, 63824-0008-10, 63824-0008-12, 63824-0008-13, 63824-0008-34, 63824-0008-50, 63824-0008-61. Recall # D-253-2012;
 
29) GUAIFENESIN/CODEINE PHOSPHATE, 100MG/10MG/5ML, ORAL SOLUTION, NDC 00121-0775-04. Recall # D-254-2012;
 
30) guanFACINE, 1 MG, TABLETS, NDC 00378-1160-01, 00591-0444-01, 65162-0711-10. Recall # D-255-2012;
 
31) GUANFACINE, 2MG, TABLETS, NDC 00591-0453-01. Recall #D-256-2012;
 
32) GUANFACINE ER, 1 MG, TABLETS, NDC 54092-0513-02. Recall # D-257-2012;
 
33) HALOPERIDOL, 20MG, TABLETS, NDC 68382-0081-01. Recall # D-258-2012;
 
34) HALOPERIDOL, 2MG/ML, SOLUTION, NDC 00093-9604-12, 00121-0581-04. Recall # D-259-2012;
 
35) HydrALAZINE HCL, 10 MG, TABLETS, NDC 05011-1398-01. Recall # D-260-2012;
 
36) HydrALAZINE HCL, 100 MG, TABLETS, NDC 31722-0522-01, 50111-0397-01, 68462-0344-01. Recall # D-261-2012;
 
37) HydrALAZINE HCL, 25 MG, TABLETS, NDC 31722-0520-01, 49884-0027-01, 50111-0327-01. Recall # D-262-2012;
 
38) HydrALAZINE HCL, 50 MG, TABLETS, NDC 23155-0003-01, 31722-0521-01, 50111-0328-01, 50111-0328-03. Recall # D-263-2012;
 
39) HYDROCHLOROTHIAZIDE, 12.5 MG, TABLETS, NDC 00228-2820-11. Recall # D-264-2012;
 
40) HYDROCHLOROTHIAZIDE, 25 MG, TABLETS, NDC 00603-3856-21, 00603-3856-32. Recall # D-265-2012;
 
41) HYDROCHLOROTHIAZIDE, 50MG, TABLETS, NDC 00603-3857-21. Recall # D-266-2012;
 
42) HYDROCHLOROTHIAZIDE/TRIAMTERENE, 25MG/37.5 MG, CAPLETS, NDC 00007-3650-22. Recall # D-267-2012;
 
43) HYDROCODONE BITARTRATE AND ACETAMINOPHEN, 5/325 MG/MG, TABLETS, NDC 00406-0365-01, 00603-3890-28, 53746-0109-01. Recall # D-268-2012;
 
44) HYDROCODONE BITARTRATE/ACETAMINOPHEN, 7.5MG/500MG/15ML, SOLUTION, NDC 00121-0655-04, 00121-0655-16. Recall # D-269-2012;
 
45) HYDROCODONE BITARTRATE/ACETAMINOPHEN, 10MG/325MG, TABLETS, NDC 00406-0367-01. Recall # D-270-2012;
 
46) HYDROCODONE BITARTRATE/HOMATROPINE METHYLBROMIDE, 5MG/1.5MG/5, NDC 00472-1030-16. Recall # D-271-2012;
 
47) HYDROCODONE/CHLORPHENIRAMINE,10 MG/8 MG/5 ML, SUSPENSION, NDC 49884-0235-33, 53014-0548-67. Recall # D-272-2012;
 
48) HYDROCODONE/CHLORPHENIRAMINE, 10MG/8MG/5ML, NDC 53014-0548-67. Recall # D-273-2012;
 
49) HYDROCORTISONE, 10 MG, TABLETS, NDC 00603-3900-21. Recall # D-274-2012;
 
50) HYDROCORTISONE, 20 MG, TABLETS, NDC 00143-1254-01, 00904-2674-60. Recall # D-275-2012;
 
51) HYDROCORTISONE, 5 MG, TABLETS, NDC 00603-3899-19. Recall # D-276-2012;
 
52) HYDROXYCHLOROQUINE SULFATE, 200 MG, TABLETS, NDC 63304-0296-01. Recall # D-277-2012;
 
53) HYDROXYUREA, 500 MG, CAPLETS, NDC 00555-0882-02, 49884-0724-01. Recall # D-278-2012;
 
54) HydrOXYzine HCL, 25 MG, TABLETS, NDC 00904-0358-60, 68462-0361-05. Recall # D-279-2012;
 
55) HydrOXYzine HYDROCHLORIDE, 10MG, TABLETS, NDC 00904-0357-40. Recall # D-280-2012;
 
56) HydrOXYzine PAMOATE, 100 MG, CAPLETS, NDC 00536-0324-02, 00555-0324-02. Recall # D-281-2012;
 
57) HydrOXYzine PAMOATE, 25MG, CAPSULES, NDC 00555-0323-02, 00591-0800-01. Recall # D-282-2012;
 
58) HydrOXYzine PAMOATE, 50 MG, CAPLETS, NDC 00555-0302-04. Recall #D-283-2012;
 
59) HYOSCY/ATRO/SCOPO/PHENOBARB, 0.1037/0.0194/0.0065/16.2 MG, TABLETS, NDC 66213-0425-10. Recall # D-284-2012;
 
60) HYOSCYAMINE SULFATE, 0.125 MG, TABLETS, NDC 00574-0246-01, 24486-0601-10, 24486-0602-10, and 68220-0112-10. Recall # D-285-2012;
 
61) HYOSCYAMINE SULFATE, 0.375 MG, Tablets, NDC 00574-0251-01. Recall # D-286-2012;
 
62) HYOSCYAMINE SULFATE SL, 0.125MG, SL/CHEW/ORAL TABLETS, NDC 24486-0603-10, 43199-0011-01. Recall # D-287-2012;
 
63) IBUPROFEN, 50 MG/1.25 ML, SUSPENSION, NDC 00904-5463-35, 37205-0646-05. Recall # D-288-2012;
 
64) IBUPROFEN, 100 MG, CHEWABLE TABLETS, NDC 50580-0207-24. Recall # D-289-2012;
 
65) IBUPROFEN, 200 MG, TABLETS, NDC 00536-3105-01. Recall # D-290-2012;
 
66) IBUPROFEN, 400 MG, TABLETS, NDC 00904-1748-40. Recall # D-291-2012;
 
67) IBUPROFEN, 600 MG, TABLETS, NDC 53746-0465-01, 53746-0465-05, 63739-0443-10. Recall # D-292-2012;
 
68) IBUPROFEN, 800 MG, TABLETS, NDC 00603-4023-28, 00904-5187-40, 00904-5187-60, 00904-5855-61. Recall # D-293-2012;
 
69) IMATINIB MESYLATE, 100 MG, TABLETS, NDC 00078-0401-34. Recall # D-294-2012;
 
70) IMATINIB MESYLATE, 400 MG, TABLETS, NDC 00078-0438-15. Recall # D-295-2012;
 
71) IMIPRAMINE HCL, 10 MG, TABLETS, NDC 00781-1762-01. Recall # D-296-2012;
 
72) IMIPRAMINE HCL, 25 MG, TABLETS, NDC 00781-1764-01, 49884-0055-01. Recall # D-297-2012;
 
73) IMIPRAMINE HCL, 50MG, TABLETS, NDC 00781-1766-01. Recall # D-298-012;
 
74) INDAPAMIDE, 2.5 MG, TABLETS, NDC 00378-0080-01. Recall # D-299-2012;
 
75) INDINAVIR SULFATE, 400 MG, CAPLETS, NDC 00006-0573-54, 00006-0573-62. Recall # D-300-2012;
 
76) INDOMETHACIN, 25 MG, CAPLETS, LLC, NDC 00781-2325-01. Recall #D-301-2012;
 
77) IRBESARTAN, 150 MG, TABLETS, NDC 00087-2772-31, 00087-2772-32. Recall # D-302-2012;
 
78) ISOSORBIDE DINITRATE, 2.5 MG, SL, TABLETS, NDC 00603-4122-21. Recall # D-303-2012;
 
79) ISOSORBIDE DINITRATE, 30MG, TABLET, NDC 00143-1773-01. Recall # D-304-2012;
 
80) ISOSORBIDE DINITRATE ER, 40 MG, TABLETS, NDC 57664-0600-88, 64980-0144-01. Recall # D-305-2012;
 
81) ISOSORBIDE MONONITRATE, 10 MG, Tablets, NDC 00228-2631-11. Recall # D-306-2012;
 
82) ISOSORBIDE MONONITRATE, 20 MG, Tablets, NDC 00228-2620-11, 62175-0107-01. Recall # D-307-2012;
 
83) ISOSORBIDE MONONITRATE ER, 120 MG, Tablets, NDC 62175-0129-37. Recall # D-308-2012;
 
84) ISOSORBIDE MONONITRATE ER, 30 MG, Tablets, NDC 00006-2175-01, 00143-2230-01, 62715-0128-37. Recall # D-309-2012;
 
85) ISOSORBIDE MONONITRATE ER, 60 MG, Tablets, NDC 00143-2260-01, 62175-0119-37. Recall # D-310-2012;
 
86) ISRADIPINE, 2.5 MG, Caplets, NDC 16252-0539-01.Recall # D-311-2012;
 
87) ITRACONAZOLE, 100 MG, Caplets, NDC 00185-0550-30. Recall # D-312-2012;
 
88) ITRACONAZOLE, 100 MG, Caplets, NDC 00185-0550-30. Recall # D-313-2012
CODE
1) Lot GG1010007-A, Exp. 11/03/11;
 
2) Lot OBFTH, Exp 05/04/12;
 
3) Lot JKJ0822A, Exp. 09/13/11, 11/24/11, 10/21/11; JKJ1611A, Exp. 08/18/11; 2101018, and 06/10/11; 021020267, Exp. 11/03/11; 0210 0855, Exp. 06/02/11;
 
4) Lot OEG740, Exp. 11/30/11;
 
5) Lot: 0HG955, Exp 12/21/11 and 02/08/12; 0MG293, Exp. 01/11/12; 0NG391, Exp. 04/10/12; OHG955, Exp 09/07/11 and 09/17/11;
 
6) Lot 0EG801, Exp. 08/17/11; 9MG193, Exp. 07/06/11; OEG801, Exp. 10/06/11 and 01/25/12; ONG395, Exp. 02/17/12 and 03/03/12;
 
7) Lot 01G797, Exp 06/03/11; 1009022, Exp 01/21/12; 1012508, Exp 02/11/12;
 
8) Lot 1127942, Exp. 07/31/11; 34G016, Exp. 10/08/11; 34G017, Exp. 11/12/11; 34G020, Exp. 12/22/11; 34G026, Exp. 04/17/12; 35G025, Exp. 04/11/12;
 
9) Lot 35G025, Exp. 12/02/11;
 
10) Lot 47255B, Exp. 09/30/11; 433993A, Exp. 07/28/11; 195983, Exp. 10/07/11; 195984, Exp. 08/11/11; 200376, Exp. 08/30/11; BM2947, Exp. 05/09/12, 05/19/12; BP1436, Exp 05/15/12; 193944, Exp 09/02/11; 194332, Exp. 06/07/11; 195264, Exp. 07/06/11, 07/28/11; 198256, Exp. 06/24/11;
 
11) Lot VO92340, Exp. 05/27/11; V100651, Exp. 12/28/11, 12/31/11; V101744, Exp. 02/23/12; V110164, Exp. 04/25/12;
 
12) Lot 011048, Exp. 04/17/12;
 
13) Lot 27559616, Exp. 06/22/11, 08/03/11, 09/15/11,10/07/11; 27559631, Exp. 07/22/11, 08/03/11, 08/25/11, 09/15/11, 10/07/11; 29374420, Exp. 09/15/11, 12/03/11: 29374423, Exp. 11/02/11, 11/22/11, 11/24/11, 12/03/11, 12/08/11, 12/21/11; 29374426, Exp. 12/20/11, 02/09/12,02/28/12; 32335711, Exp 05/02/12; 91915, Exp. 02/18/12, 03/22/12, 04/07/12; 86414A, Exp. 02/02/12; 4963000, Exp. 03/29/12, 03/31/12; 5144202, Exp. 02/09/12; 5317500, Exp 03/28/12, 04/24/12, 05/05/12;
 
14) Lot 89142B, Exp. 05/04/12;
 
15) Lot C3018B, Exp. 03/28/12; C3071B, Exp. 02/08/12, 03/31/12; 87637C, Exp. 01/26/12, 03/23/12; 89417C, Exp. 01/14/12; 97040A, Exp. 05/03/12; 101632, Exp. 02/09/12;
 
16) Lot 35312885B, Exp. 05/31/11; 35315212A, Exp. 09/13/11, 09/30/11; 35315213A, Exp. 09/30/11; 35317044A, Exp. 02/14/12; 103614, Exp. 08/30/11; GB1210001-A, Exp. 01/31/12;
 
17) Lot 35201677A, Exp. 04/11/12; 35201679A, Exp. 05/05/12, 05/11/12, 05/15/12; 35312297A, Exp. 07/02/11; 35312298A, Exp. 07/20/11; 35312301B, Exp 10/25/11, 11/11/11; 35316206A, Exp. 09/07/11, 09/15/11; 35316207A, Exp. 09/20/11, 09/21/11, 10/15/11, 11/11/11, 04/11/12; 35317567A, Exp. 11/19/11, 12/22/11; 103845, Exp 08/06/11; 104537, Exp 08/11/11, 08/16/11, 08/18/11;
 
18) Lot 35314911A, Exp. 10/18/11; 35315771A, Exp. 10/18/11; 35315781A, Exp. 10/25/11; 35317371B, Exp. 01/12/12, 02/03/12; 35317763A, Exp. 02/08/12, 02/24/12;
 
19) Lot 10T5020, Exp 04/03/12;
 
20) Lot 10T0710, Exp 07/27/11; 10T7310A, Exp 01/26/12; 10T7570, Exp 02/10/12;
 
21) Lot TE04128, Exp.10/28/11;
 
22) Lot 534475, Exp. 11/04/11; 535198, Exp. 12/17/11;
 
23) Lot 18011591, Exp. 01/12/12, 05/18/12; 18012445, Exp. 05/18/12; 18012461, Exp. 05/18/12; 101932, Exp. 08/09/11; 105422, Exp. 03/09/12, 03/31/12; 1019332, Exp. 08/31/11;
 
24) Lot T141B11A, Exp. 03/30/12; 18009128, Exp. 10/31/11; 18011592, Exp. 02/15/12; 18011712, Exp. 03/09/12; 18012462, Exp. 04/13/12; 18012909, Exp 05/18/12; 18012969, Exp. 05/18/12; 101935, Exp. 06/03/11; 103103, Exp. 06/03/11, 06/30/11; 104860, Exp. 12/07/11, 12/21/11, 01/12/12, 01/31/12;
 
25) Lot 606547, Exp. 01/10/12;
 
26) Lot 8EA2903, Exp. 01/13/12; 8GA2940, Exp. 11/24/11, 12/27/11; 8JA3023, Exp. 03/28/12;
 
27) Lot T057H10A, Exp. 02/03/12, 03/16/12; T058H10A, Exp. 03/16/12; T111B10A, Exp. 06/02/11; T137F10A, Exp. 11/16/11; T146J10A, Exp. 03/01/12; T148J10A, Exp. 03/16/12; T161G10A, Exp. 12/15/11; T165G10A, Exp. 12/15/11; 00904-5154-60, Exp. 10/08/11; P59815, Exp. 10/31/11; P60410, Exp. 11/30/11; P68173, Exp. 04/14/12; P68444, Exp. 04/25/12;
 
28) Lot WO00485408, Exp. 02/03/12; WO00447615, Exp. 06/14/11; WO00448642, Exp. 05/27/11; WO00450767, Exp. 06/29/11; WO00455420, Exp. 07/26/11, 07/30/11, 08/04/11, 08/17/11, 09/24/11, 09/28/11, 10/05/11; WO00455434, Exp. 08/26/11, 09/10/11, 09/15/11, 11/19/11; WO00466640, Exp. 01/07/12, 03/16/12, 04/13/12; WO00466641, Exp. 10/26/11, 10/28/11, 11/08/11, 11/15/11, 12/03/11, 12/23/11, 12/27/11, 12/29/11, 02/11/12, 02/14/12, 02/17/12, 02/24/12, 03/13/12, 03/15/12, 03/23/12, 03/28/12, 04/10/12, 04/24/12, 04/26/12, 04/27/12, 05/02/12, 05/05/12, 05/09/12, 05/17/12, 05/19/12; WO00496482, Exp. 04/21/12; WO0455434, Exp. 10/12/11; WO00472190, Exp. 10/13/11, 10/27/11, 10/28/11, 12/07/11, 12/13/11, 12/14/11, 12/21/11,12/28/11, 12/30/11, 01/13/12, 02/02/12, 02/03/12,02/08/12, 02/25/12, 02/28/12, 03/03/12; WO00489351, Exp. 04/17/12, 04/18/12, 05/12/12; WO00493397, Exp. 03/14/12; WO00496482, Exp. 03/15/12, 03/17/12, 03/29/12, 04/12/12, 04/26/12, 04/28/12, 05/03/12, 05/05/12; WO00500319, Exp. 04/03/12; WO00450664, Exp. 06/10/11; WO00459540, Exp. 07/20/11; WO00470862, Exp. 01/18/12; WO00472192, Exp. 11/16/11, 12/08/11, 02/11/12; WO00472194, Exp. 03/16/12; WO00493543, Exp. 04/14/12; WO00417725, Exp. 06/23/11; WO00423264, Exp. 10/11/11; WO00460288, Exp. 12/29/11; WO00460288A, Exp. 12/21/11; WO00462708, Exp. 11/11/11; WO00462708A, Exp. 11/19/11; WO00473589, Exp. 10/21/11, 11/05/11, 11/19/11, 12/01/11, 12/30/11, 01/04/12, 01/13/12, 01/25/12, 01/26/12; WO00480062, Exp. 04/18/12, 04/24/12, 05/04/12; WO00485408, Exp. 02/10/12, 02/22/12, 03/01/12, 03/07/12, 03/20/12, 03/29/12, 04/06/12, 04/11/12; WO00489353, Exp. 04/06/12;
 
29) Lot 0D91, Exp. 02/04/12; 0L81, Exp. 02/04/12;
 
30) Lot 3017415, Exp. 09/13/11; 44345A, Exp. 07/12/11, 07/27/11, 08/06/11, 08/12/11; 44346A, Exp. 08/05/11, 08/06/11, 08/20/11, 08/24/11, 09/10/11; 44347A, Exp. 06/15/11, 06/16/11, 06/29/11, 07/02/11, 07/12/11; 44592A, Exp. 09/17/11; 44601A, Exp. 09/20/11, 09/23/11, 09/30/11; 45204A, Exp. 10/07/11, 10/11/11, 10/15/11, 10/28/11, 10/29/11, 10/31/11; 45210A, Exp. 10/31/11; 47244A, Exp.10/31/11; 47482A, Exp. 11/19/11, 11/24/11; 47485A, Exp. 11/30/11; 51633A, Exp. 01/06/12, 01/10/12; 51636A, Exp. 01/17/12; 51637A, Exp. 12/10/11; 51639A, Exp. 01/17/12, 01/25/12; 58780A, Exp. 02/15/12; 58870A, Exp. 03/08/12; 67085A, Exp. 03/08/12, 03/15/12, 03/28/12; 67090A, Exp. 03/30/12; 67108A, Exp. 03/30/12, 04/17/12, 04/27/12; 81820A, Exp. 04/24/12, 05/05/12, 05/08/12; BB1910, Exp. 08/31/11;
 
31) Lot 47983A, Exp. 01/28/12;
 
32) Lot 9H6777, Exp. 02/16/12; 9H6778, Exp. 02/22/12;
 
33) Lot MK1919, Exp. 10/11/11, 11/02/11; MK4426, Exp. 11/19/11, 12/08/11, 12/10/11, 04/19/12; MK6388, Exp. 01/19/12, 02/29/12, 04/10/12; MK7725, Exp. 03/27/12, 04/19/12, 05/15/12, 05/19/12;
 
34) Lot 30211412A, Exp. 10/31/11; 30211986A, Exp. 10/21/11, 12/22/11, 12/31/11; 30212731A, Exp. 12/09/11, 12/22/11, 01/03/12, 01/12/12, 03/06/12, 03/23/12; 30212745A, Exp. 12/09/11, 01/31/12, 03/06/12, 03/31/12, 04/30/12, 05/19/12; 30212746A, Exp. 03/06/12; 30214041A, Exp. 03/23/12, 04/07/12, 04/14/1, 05/05/12, 05/09/12, 05/15/12, 05/17/12, 05/19/12; 30211684A, Exp. 12/31/11; 9H14, Exp. 08/31/11;
 
35) Lot 317450, Exp. 11/17/11, 03/21/12;
 
36) Lot E100609, Exp. 02/11/12; E100626, Exp. 03/31/12; E100644, Exp. 04/21/12; 315328, Exp 07/01/11; 2900939, Exp. 06/30/11;
 
37) Lot E100576, Exp. 02/10/12; 22820701, Exp. 02/02/12; 317594, Exp. 02/16/12, 02/17/12;
 
38) Lot 6160004A, Exp. 02/04/12; 6160017A, Exp. 02/04/12; E100589A, Exp. 04/14/12; 315844, Exp. 09/02/11; 315912, Exp. 09/30/11; 315567, Exp 09/30/11;
 
39) Lot 422B11, Exp. 04/25/12, 05/12/12, 05/15/12;
 
40) Lot C0070910B, Exp. 11/05/11, 11/17/11, 11/30/11,12/16/11,12/21/11, 12/30/11; C0240710B, Exp. 09/30/11, 10/11/11, 11/05/11, 01/28/12; C0380510B, Exp. 06/09/11, 06/23/11, 07/01/11,07/28/11, 06/24/11; C0461010B, Exp. 12/21/11, 01/11/12; C0480610A, Exp. 07/15/11, 07/28/11, 08/16/11, 08/25/11, 08/26/11, 09/07/11, 09/15/11; C0690311A, Exp. 04/27/12, 05/08/12, 05/19/12; C0981110A, Exp. 02/02/1, 02/21/12, 02/29/12, 03/01/12, 03/07/12, 03/16/12, 03/20/12, 04/12/12; C1280510B, Exp. 07/01/11, 09/15/11, 10/21/11, 10/27/11, 11/05/11, 01/28/12; C0460510A, Exp. 06/07/11; C0510510A, Exp. 07/28/11; C0530610A, Exp. 07/28/11; C1051110A, Exp. 02/29/12; C1430810A, Exp. 09/30/11; C1490610A, Exp. 09/02/11; 
 
41) Lot C0590610A, Exp. 09/16/11;
 
42) Lot 0L002, Exp. 03/14/12; 1B001, Exp. 05/11/12;
 
43) Lot 0365P75356, Exp. 10/06/11; 0365P75636, Exp. 09/29/11; 0365P76218, Exp. 10/21/11; 0365P76938, Exp. 12/14/11; 0365P77447, Exp. 01/10/12, 01/19/12; 0365T77823, Exp. 03/30/12, 04/27/12; 0365T77824, Exp. 03/29/12, 03/30/12; 0365T78769, Exp. 04/25/12; 0365T78918, Exp. 05/12/12, 05/17/12; 0365P76454, Exp. 11/12/11,11/29/11; T0808B10B, Exp. 07/13/11; T081B10B, Exp. 07/13/11; HK38910, Exp. 01/13/12;
 
44) Lot 0D39, Exp. 10/31/11; 0H01, Exp. 02/29/12; OA42, Exp. 06/10/11, 07/31/11; OA56, Exp. 07/31/11; OA79, Exp. 07/31/11; OG16, Exp. 01/25/12;
 
45) Lot 0367T78153, Exp. 03/15/12;
 
46) Lot L101064, Exp. 02/29/12; L102020, Exp. 05/01/12;
 
47) Lot M11015A, Exp. 03/01/12; M11024A, Exp. 03/10/12, 04/27/12; M11041A, Exp. 04/27/12, 05/04/12, 05/16/12; 53643, Exp.12/22/11; 53795, Exp. 06/18/11;
 
48) Lot 53643, Exp. 07/13/11;
 
49) Lot T035B10A, Exp. 06/09/11; T045B10A, Exp. 06/02/11; T134H10A, Exp. 10/11/11, 03/13/12; T135H10A, Exp. 10/08/11, 10/11/11, 10/13/11; T137J10A, Exp. 01/07/12; T138J10A, Exp. 01/27/12, 02/02/12, 02/11/12; T148H10A, Exp. 10/19/11, 11/08/11, 11/18/11, 11/24/11; T151K10A, Exp. 03/01/12; T152K10A, Exp. 04/18/12; T153K10A, Exp. 03/21/12; T154K10A, Exp. 03/21/12; T155K10A, Exp. 04/26/12, 05/08/12; T156K10A, Exp. 04/04/12; T222J10A, Exp. 12/17/11, 02/22/12;
 
50) Lot 67750B, Exp. 11/09/11, 11/17/11; 67753A, Exp. 02/11/12; 68468A, Exp. 04/14/12, 04/25/12; 66084A, Exp 09/14/11;
 
51) Lot T044D10B, Exp. 08/05/11; T132H10A, Exp. 10/08/11; T133H10A, Exp. 12/21/11; T146G10A, Exp. 10/19/11; T147H10A, Exp. 11/29/11; T155B10A; Exp. 06/04/11, 06/21/11, 02/28/12; T158K10A, Exp. 02/11/12, 02/23/12; T286B11A, Exp. 04/24/12, 05/19/12;
 
52) Lot CDB0003AC, Exp. 07/26/11; CDB0031AC, Exp. 02/24/12;
 
53) Lot 316930, Exp. 10/28/11; 22820501, Exp. 03/15/12;
 
54) Lot L2437A, Exp. 05/04/12; 1002189, Exp. 06/03/11;
 
55) Lot 10280, Exp. 06/03/11;
 
56)Lot 315866, Exp. 08/25/11; 314770, Exp 06/16/11; 315054, Exp. 06/22/11, 06/25/11, 07/08/11, 09/16/11; 315866, Exp. 07/22/11, 07/23/11, 08/16/11, 09/03/11, 09/10/11, 09/15/11; 315868, Exp. 08/24/11, 08/26/11, 09/10/11, 09/15/11; 317420, Exp. 10/25/11, 10/27/11; 317422, Exp. 11/02/11, 11/19/11, 11/24/11; 317941, Exp. 01/03/12, 01/21/12, 02/02/12; 34001095, Exp. 04/07/12; 04/31/2013, 08/25/11; 34001095A, Exp. 04/18/12, 04/13/12, 04/19/12, 05/02/12, 05/19/12; 34001906A, Exp. 05/11/12, 05/15/12;
 
57) Lot 314984, Exp. 06/16/11; 3076913, Exp. 08/04/11; 3078760, Exp. 07/22/11;
 
58) Lot 34000669A, Exp. 03/14/12;
 
59) Lot 66613B, Exp. 06/23/11, 04/27/12;
 
60) Lot 1115005, Exp. 05/05/12; 0040151, Exp. 06/21/11; YHZ9, Exp. 06/23/11; YKT9, Exp 06/29/11, 07/26/11, 07/30/11; YLT9, Exp.10/12/11, 11/05/11, 11/15/11; YLU9, Exp. 11/18/11; YLX9, Exp. 01/03/12, 01/13/12, 04/28/12; YLZ9, Exp. 01/19/12, 01/25/12, 02/22/12, 04/03/12; YNP10, Exp. 03/06/12, 04/19/12; YNQ10, Exp. 02/29/12, 03/03/12; YCJ10, Exp. 09/02/11; YHX10, Exp. 11/30/11; YMY10, Exp. 04/14/12; YAJ10, Exp. 12/20/11, 01/10/12, 01/31/12; YPB10, Exp 02/16/12, 02/21/12;
 
61) Lot 0493851, Exp.04/26/12; 514091, Exp.04/24/12;
 
62) Lot YJT9, 01/03/12; 500653, Exp. 12/30/11;
 
63) Lot 0JK0146, Exp.12/17/11; 0JK0321, Exp. 12/17/11, 01/05/12, 03/21/12; 0KK0461, Exp. 03/21/12; 0KK0496, Exp. 04/04/12; 9KK0396, Exp. 05/27/11; OBK0168, Exp. 05/27/11, 06/18/11; OJK0146, Exp. 10/31/11; OKK0461, Exp. 01/05/12, 04/04/12; 0HK0246, Exp. 09/01/11, 10/06/11; OHK0246, Exp. 09/07/11, 09/13/11;
 
64) Lot BCM220, Exp. 06/02/11, 11/26/11;
 
65) Lot 32302, Exp. 06/09/11; 32894, Exp. 08/25/11;
 
66) Lot HF07810, Exp.11/17/11;
 
67)Lot HA28610, Exp. 08/03/11; HE04510, Exp. 10/26/11; HG37410, Exp. 01/28/12, 02/11/12; HG37810, Exp. 11/24/11; 68196, Exp. 08/05/11;
 
68) Lot HH11609, Exp. 07/28/11; HH11709, Exp. 06/07/11; HC36810, Exp. 09/02/11, 09/30/11; HD33610, Exp. 09/02/11; HA16210, Exp. 06/30/11; HA16310, Exp. 06/30/11; P-14252, Exp. 08/05/11;
 
69) Lot F0034, Exp. 05/11/12;
 
70) Lot F0141, Exp. 05/11/12;
 
71) Lot 195304, Exp. 08/30/11, 09/24/11, 10/08/11, 10/12/11; 201215, Exp 01/05/12; BH5601, Exp. 04/11/12, 04/14/12;
 
72) Lot 197905, Exp. 10/25/11; 201216, 01/11/12; BH1571, Exp. 03/14/12, 03/17/12, 04/26/12, 04/28/12; 22555501, Exp. 05/09/12;
 
73) Lot 194781, Exp. 08/31/11; 1925787, Exp. 06/02/11;
 
74) Lot 3017592, Exp. 08/17/11;
 
75) Lot E010452, Exp. 04/14/12; E008263, Exp. 04/13/12;
 
76) Lot 204179, Exp. 02/22/12;
 
77) Lot 0B58443A, Exp. 11/23/11; 0G56567A, Exp. 12/01/11; 0G56573B, Exp. 12/08/11, 12/13/11; 0K65089A, Exp. 02/14/12; 0L58537A, Exp. 03/23/12; 1A65218A, Exp. 04/25/12, 05/18/12; O62509A, Exp. 10/31/11; OG56578A, Exp. 01/03/12, 02/08/12; OK65088A, Exp. 02/07/12; 0K65090A, Exp. 02/02/12;
 
78) Lot 61283D, Exp. 04/27/12;
 
79) Lot 68185B, Exp. 12/28/11;
 
80) Lot 1072763, Exp. 08/16/11, 08/23/11, 09/02/11; 1084411, Exp. 02/15/12; 1086278, Exp. 05/01/12; 103888, Exp. 07/08/11;
 
81) Lot 213A01, Exp. 10/08/11;
 
82) Lot 439D01, Exp. 02/29/12; 492L91, Exp. 07/07/11; 630H01, Exp. 12/10/11, 02/16/12; 929L01, Exp. 04/27/12; 962101, Exp. 10/08/11;
 
83) Lot 995301, Exp. 12/30/11;
 
84) Lot 0988301, Exp. 12/27/11; 68237A, Exp. 03/15/12; 0002101, Exp. 02/29/12, 03/01/12, 03/09/12; 0002201, Exp. 03/10/12, 03/13/12, 03/15/12; 12201, Exp. 03/21/12; 0012201, Exp. 03/28/12; 0012301, Exp. 04/06/12, 04/07/12, 04/10/12, 04/11/12, 04/13/12; 0016401, Exp. 05/03/12, 05/04/12; 41425, Exp. 08/30/11; 923802, Exp. 05/27/11; 923901, Exp. 06/02/11, 06/10/11; 924001, Exp. 06/14/11, 06/17/11; 936901, Exp. 07/01/11; 937001, Exp. 07/08/11, 07/12/11; 937102, Exp. 07/14/11; 937201, Exp. 07/09/11, 07/12/11; 942001, Exp. 07/22/11, 08/03/11; 942101, Exp. 08/06/11, 08/11/11, 08/17/11; 947601, Exp. 08/31/11; 956201, Exp. 09/16/11; 956301, Exp. 09/20/11, 09/22/11, 09/24/11; 960201, Exp. 10/06/11; 964501, Exp. 10/21/11; 0965901, Exp. 11/11/11; 0968601, Exp. 11/11/11; 0973402, Exp. 12/07/11; 981401, Exp. 12/08/11; 0981401, Exp. 12/08/11, 12/17/11; 0981501, Exp. 12/10/11, 12/13/11,12/21/11, 12/30/11; 0988301, Exp. 01/03/12, 01/05/12, 01/07/12; 0992601, Exp. 01/18/12, 02/29/12; 0992801, Exp. 01/25/12; 0998601, Exp. 01/27/12, 01/31/12, 02/03/12; 0998701, Exp. 02/04/12, 02/08/12; 0998801, Exp. 02/16/12, 02/17/12, 03/07/12, 04/27/12; 0998901, Exp. 03/16/12, 03/20/12; 1025502, Exp. 04/26/12, 05/01/12, 05/04/12, 05/05/12; 1025601, Exp. 05/10/12, 05/12/12, 05/17/12; 0923901, Exp. 07/02/11; 0936901, Exp. 06/18/11, 06/21/11, 06/22/11; 0937001, Exp. 06/25/11; 0947601, Exp. 09/10/11; 0960201, Exp. 09/30/11; 0960401, Exp. 10/25/11, 10/26/11, 10/31/11; 0964501, Exp. 10/19/11, 10/25/11; O960301, Exp. 10/11/11; O964501, Exp. 11/11/11; O968701, Exp. 11/26/11; 0942101, Exp. 08/05/11, 08/18/11;
 
85) Lot 67591A, Exp. 07/22/11; 67882A, Exp. 09/24/11; 0000701, Exp. 02/09/12, 02/29/12; 0007301, Exp. 04/04/12, 04/06/12; 009401, Exp. 04/12/12; 0012501, Exp. 05/04/12; 915901, Exp. 05/27/11; 933901, Exp. 07/01/11, 07/08/11; 953401, Exp. 09/30/11; 0971301, Exp. 11/10/11; 0981601, Exp. 12/17/11, 12/27/11, 12/28/11; 0991101, Exp. 02/29/12; 0991201, Exp. 02/24/12, 02/29/12; 0995601, Exp. 02/17/12; 0995701, Exp. 02/29/12, 03/10/12; 0943801, Exp. 09/22/11; 0953302, Exp. 10/08/11; O971401, Exp. 11/26/11;
 
86) Lot B09060A, Exp.10/29/11; B09081A, Exp. 02/10/12;
87) Lot 193263, Exp. 11/24/11, 02/28/12;
 
88) Lot 193263, Exp. 11/24/11, 02/28/12
RECALLING FIRM/MANUFACTURER
Aidapak Services, LLC, Vancouver, WA, by letters on May 27, 2011, May 28, 2011 and May 31, 2011 and by press release on June 1, 2011. Firm initiated recall is ongoing.
REASON
There is a potential for Penicillin cross contamination.
VOLUME OF PRODUCT IN COMMERCE
Total 3,524,891 dosage units (186,637 units for drug G-I)
DISTRIBUTION
AK, CA, OR. NV, WA
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II ___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2161-11
CODE
Units: 003LS72544; 003LS71434
RECALLING FIRM/MANUFACTURER
The American National Red Cross – Southern Region, Douglasville, GA, by facsimile on July 17, 2011. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
___________________________________
PRODUCT
Source Plasma, Recall # B-2185-11
CODE
Units: 11MTNA9018; KZ109275; KP125619
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by fax and e-mail on July 28, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Austria, Canada, CA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0001-12
CODE
Unit: W142811132271
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tri-counties Blood Bank, San Luis Obispo, CA, by telephone on July 8, 2011. 
Manufacturer: Tri-Counties Blood Bank dba UBS- Central Coast, Santa Barbara, CA. Firm initiated recall is complete.  
REASON
Blood product, which did not meet the specification for absolute volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0002-12
CODE
Unit: W141611512846
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by telephone on July 28, 2011. 
Manufacturer: Puget Sound Blood Center and Program, Bellingham, WA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0003-12
CODE
Unit: W141611010914
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by telephone on July 28, 2011.  
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Source Plasma. Recall # B-0008-12
CODE
Units: 10JMOD4345, 10JMOD3474
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Joplin, MO, by electronic notification on June 27, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Reagent Red Blood Cells 20 x 3 mL Expiration Date - 2010-11-05.  B-0013-12
CODE
Unit: 35385
RECALLING FIRM/MANUFACTURER
Immucor Inc., Norcross, GA, by letter on October 6, 2010. Firm initiated recall is complete.
REASON
Reagent Red Blood Cell, listed as Jka negative on the Master List was identified as possessing a weak expression of the Jka antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
839 units
DISTRIBUTION
Nationwide, and Australia, Bahrain, Canada, Denmark, England, Germany, Hong Kong, Ireland, Israel, Japan, Saudi Arabia, US Virgin Islands
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-0029-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0030-12
CODE
1) Unit: W089810408926;
2) Units: W089811402509 (2 units), W089810408926
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Inova Blood Donor Services, Sterling, VA, by letters dated July 25, 2011 and August 30, 2011, by e-mail on July 25, 2011, and by facsimile on August 31, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
VA, Washington D.C.
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0031-12
CODE
Unit: W115111218734L
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on July 12, 2011. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled as leukoreduced, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Irradiated. Recall # B-0032-12
CODE
Unit: W037911156546
RECALLING FIRM/MANUFACTURER
LifeServe Blood Center, Des Moines, IA, by telephone on August 11, 2011. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0033-12
CODE
Unit: W088411528005
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, Hawaii, by letter dated August 23, 2011. 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
HI
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-0060-12;
2) Cryoprecipitated AHF Pooled. Recall # B-0061-12
CODE
1) Unit: W037711118214;
2) Unit: W037711501139
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by telephone and electronic mail on June 20, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland, OH
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0062-12
CODE
Unit: W037708011250
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH,by electronic mail on July 21, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall #B-0063-12
CODE
Unit: W2906110261192
RECALLING FIRM/MANUFACTURER
Penrose-St Franc Health Services Blood Bank, Colorado Springs, CO, by telephone on August 22 and 23, 2011. Firm initiated recall is complete.
REASON
Blood product, which did not meet the acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall #B-0092-12
CODE
Unit: 11631110535900I
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., Pensacola, FL, by telephone and facsimile on August 26, 2011. 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
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall #B-0093-12
CODE
Units: W043211051467, W043211020790
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on September 6, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN, GA
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Source Plasma. Recall # B-0012-12
CODE
Units: 11VMND2628, 11VMND0404
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Mounds View, MN, by electronic notification on July 20, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who previously tested positive for the human immunodeficiency virus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Reagent Red Blood Cells For Use in Automated Systems Since (1 Plate), 5 Plates Exp. Date 2010-09-28. Recall # B-0014-12
CODE
Unit: E029
RECALLING FIRM/MANUFACTURER
Immucor Inc., Norcross, GA, by letter on August 3, 2010. Firm initiated recall is complete.
REASON
Capture-R Ready-Screen Cell, with reports of unexpected weak positive reactivity, was distributed.
VOLUME OF PRODUCT IN COMMERCE
153 units
DISTRIBUTION
Germany, Ireland, Israel, Norway, Peru and South Africa
___________________________________
PRODUCT
Reagent Red Blood Cells 20 x 3 mL. Recall # B-0015-12
CODE
Unit: 29304
RECALLING FIRM/MANUFACTURER
Immucor Inc., Norcross, GA, by letter on August 30, 2010. Firm initiated recall is complete. 
REASON
Panocell-20, demonstrating weak positive reactions in the direct antiglobulin test (DAT), with Cell 5, was distributed.
VOLUME OF PRODUCT IN COMMERCE
850 units
DISTRIBUTION
Nationwide and Australia, Bahrain, Canada, China, Denmark, England, Germany, Guam, Hong Kong, Ireland, Japan, Saudi Arabia, U.S. Virgin Island.
___________________________________
PRODUCT
Gamma-clone Anti-Le (Murine Monoclonal) 1 x 5 mL Exp. date 2012-08-20. Recall # B-0016-12
CODE
Unit: 992006
RECALLING FIRM/MANUFACTURER
Immucor Inc., Norcross, GA, by letter on June 16, 2011. Firm initiated recall is complete.
REASON
Gamma-clone Anti-Leb, with weak reactivity with rare examples of Le(a+b-) red blood cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1448 units
DISTRIBUTION
Nationwide, and Argentina, Australia, Bahrain, Canada, China, Costa Rica, Denmark, Germany, Hong Kong, India, Ireland, Israel, Japan, Mexico, Moldova, Norway, Peru, Philippines, Saudi Arabia, Sweden, Taiwan, US Virgin Islands
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
1) Philips GEMINI TF16 Diagnostic Imaging Systems, Model Number: 882470, 510(k) #K052640. The recalled GEMINI TF16 system units equipped with software versions: 3.5.1.1 and 3.5.2.1 are subject to recall/software correction. The GEMINI TFI6, TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner. Recall # Z-3199-2011;
 
2) Philips GEMINI TF64 Diagnostic Imaging Systems, Model Number: 882471, 510(k) #K052640. The recalled GEMINI TF64 system units equipped with software versions: 3.5.1.1 and 3.5.2.1 are subject to recall/software correction. The GEMINI TFI6, TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner. Recall # Z-3200-2011;
 
3) Philips GEMINI TF Big Bore (BB) Diagnostic Imaging Systems, Model Number: 882476, 510(k) #K081135. The recalled GEMINI TF Big Bore system units equipped with software version: 3.6.1 are subject to recall/software correction. The GEMINI TFI6, TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner. Recall # Z-3201-2011
CODE
1) Serial Numbers: 7501, 7503, 7507, 7508, 7011, 7047, and 7174;
2) Serial Numbers: 7502, 7504, 7506, 7514, 7083 and 7164;
3) Serial Numbers: 9201, 9202, 9203, 9204, 9205, and 9206
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated August 9, 2011. Firm initiated recall is ongoing.
REASON
The firm is conducting a recall/software correction to several of their GEMINI PET/CT X-ray system units in the field. The firm believes that if these software defects were to recur, it could impact the performance of reliability of these PET/CT system units.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
Nationwide, France, Germany, Italy, Kuwait, The Netherlands, Spain and Turkey
___________________________________
PRODUCT
1) PHILIPS NM3 Monitor Model Number: 7900 PHILIPS NM3 Monitor, English Part Number: 1051674 PHILIPS NM3 Monitor, English, Refurbished Part Number : U1051674 PHILIPS NM3 Monitor, English, Demo Unit Part Number: DU1051674 PHILIPS NM3 Monitor, Spanish Part Number: 1060462 PHILIPS NM3 Monitor, French Part Number: 1060458 PHILIPS NM3 Monitor, Swedish Part Number:1062860 Intended use: Cardiac output monitoring, Spirometric and carbon dioxide monitoring, and Continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate. Recall # Z-3287-2011;
 
2) FloTrak Elite modules FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005. Recall # Z-3288-2011
CODE
1) Serial Numbers Domestic: 00401 00189 00209 00049 00191 00194 00211 00339 00362 00290 00291 00294 00295 00297 00300 00301 00302 00309 00311 00119 00360 00306 00451 00455 00212 00357 00351 00075 00111 00115 00126 00129 00132 00096 00120 00121 00123 00125 00127 00128 00131 00057 00110 00133 00150 00173 00214 00326 00058 00066 00063 00070 00145 00041 00055 00148 00245 00082 00184 00188 00203 00204 00254 00399 00400 00167 00207 00241 00242 00248 00249 00250 00251 00130 00377 00353 00352 00358 00354 00355 00359 00042 00124 00272 00113 00210 00240 00164 00218 00303 00304 00308 00160 00172 00217 00364 00087 00089 00298 00314 00322 00078 00313 00315 00084 00092 00219 00252 00266 00279 00285 00286 00246 00244 00243 00340 00345 00346 00349 00365 00372 00375 00380 00382 00383 00384 00385 00387 00388 00392 00366 00208 00104 00391 00097 00102 00361 00363 00367 00368 00225 00374 00404 00411 00370 00373 00193 00222 00423 00427 00114 00118 00067 00398 00183 00186 00262 00293 00331 00333 00335 00336 00261 00299 00356 00267 00046 00122 00154 00109 00190 00247 00394 00381 00378 00369 00074 00080 00081 00098 00103 00105 00107 00116 00187 00071 00072 00073 00076 00083 00088 00093 00100 00101 00117 00112 00344 00376 00277 00289 00079 00099 00106 00108 00317 00319 00321 00085 00318 00320 00135 00200 00265 00280 00144 00179 00181 00182 00205 00077 00086 00090 00091 00094 00195 00198 00253 00255 00256 00260 Foreign: 00379 00422 00425 00476 00389 00428 00305 00310 00350 00409 00421 00269 00273 00274 00275 00287 00288 00263 00237 00332 00323 00316 00390, and 00393;
 
2) Serial Numbers 525 539 146 155 171 173 178 611 612 150 165 231 234 175 235 236 237 238 239 240 356 376 389 414 000475 483 000496 502 510 511 686 693 700 723 724 725 167-000385 167-000487 232 000372, and 000834
RECALLING FIRM/MANUFACTURER
Respironics Novametrix, LLC, Wallingford, CT, by letter on on July 29, 2011. Firm initiated recall is ongoing.
REASON
Pressure lines maybe occluded and display incorrect tidal volumes.
VOLUME OF PRODUCT IN COMMERCE
295 units
DISTRIBUTION
Nationwide, Belgium, Canada, Chile, Columbia, Egypt, India, Italy, Spain, Saudi Arabia Thailand, GB, and Russia
___________________________________
PRODUCT
Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO. The cochlear implant is intended to restore a level of auditory sensation via the electrical stimulation of the auditory nerve. Recall # Z-0003-2012
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cochlear Americas Inc., Englewood CO, by letter dated September 16, 2011.
Manufacturer: Cochlear Limited, Lane Cove, NSW, Australia. Firm initiated recall is ongoing.
REASON
Cochlear implant may shut down and cease to function.
VOLUME OF PRODUCT IN COMMERCE
33,645 units (global); 25,516 (implanted); 1,741 remaining in U.S. Market for implantation
DISTRIBUTION
Nationwide, Europe and Australia
___________________________________
PRODUCT
Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks. Recall # Z-0039-2012
CODE
Serial Nos: 34450, 34519, 34520, 34601, 34662, 34665, 34807, 34922, 35030, 35032, 35033, 35159, 35637, 35793, 35976, 35978, 35978, 38337, 38584, 38651, 39238, 39280, 39281, 39542, 39795, 40607, 41039, 45104, 45367, 45369, 45371, 45760, 45845, 47466, 47467, 47468, 47469, 47772, 47773, 47774, 47775, 47776, 48095, 48096, 48097, 48098, 48109, 48110, 48111, 48112, 48113, 48114, 48115, 48116, 48184, 48252, 48253, 48254, 48259, 48260, 48261, 48314, 48315, 48593, 48594, 48910, 48911, 48912, 48913, 48914, 48915, 48916, 48917, 48918, 48919, 48920, 48921, 48922, 48923, 48924, 48978, 48978, 49102, 49103, 49104, 49105, 49106, 49107, 49108, 49109, 49110, 49209, 49209, 49210, 49210, 49211, 49211, 49212, 49213, 49213, 49214, 49214, 49221, 49223, 49230, 49286, 49287, 49288, 49289, 49290, 49291, 49292, 49293, 49294, 49295, 49296, 49297, 49298, 49299, 49300, 49301, 49302, 49303, 49304, 49305, 49306, 49307, 49308, 49309, 49310, 49311, 49312, 49962, 49963, 49964, 49965, 49966, 49967, 49968, 49969, 49970, 49971, 49972, 49973, 49974, 49975, 49976, 49977, 49978, 49989, 49990, 49991, 49992, 49993, 49994, 49995, 50221, 50222, 50224, 50225, 50226, 50578, 50579, 50580, 50581, 50582, 50583, 50584, 50585, 50586, 50587, 50676, 50677, 50678, 50679, 50680, 50681, 50791, 50792, 50793, 50794 and 50911
RECALLING FIRM/MANUFACTURER
Recalling Firm: Richard-Allan Scientific, Co., Kalamazoo, MI, by letter beginning August 12, 2011.
Manufacturer: Microm International Gmbh, Walldorf, Germany. Firm initiated recall is ongoing.
REASON
The firm has received two complaints of finger lacerations in operators of this device.
VOLUME OF PRODUCT IN COMMERCE
786 units
DISTRIBUTION
Nationwide and Canada
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III ___________________________________
PRODUCT
Stryker SmartPump Extension Tubing (Pneumatic tourniquet). Sterile tubing extension a) 40 ",  Part number 5920-000-005; and b) 60", Part number 5920-000-005, set, luer lock. Rx only. Optional accessories used with the Stryker SmartPump Tourniquet System. The luer locks are intended to be connected to the tourniquet pump - to fill the line - and to the cuff. The extension tubing is an optional accessory used to connect the tourniquet cuff with the pump when a longer distance between the pump and the tourniquet is desired. The extension tubing comes packaged 10 per box. Recall # Z-3274-2011
CODE
b) lot number 11138012; b) lot number 11137012
RECALLING FIRM/MANUFACTURER
Stryker Instruments Div. of Stryker Corp., Portage, MI, by letter dated August 22, 2011.
Manufacturer: Stryker Puerto Rico LtdArroyo, PR. Firm initiated recall is ongoing.
REASON
The product inside the package did not match the label description. The units had quick connectors instead of luer lock connectors as stated in the label description.
VOLUME OF PRODUCT IN COMMERCE
5920-000-003 (8 box) 5920-000-005 (14 box)
DISTRIBUTION
Nationwide and France
 
END OF ENFORCEMENT REPORT FOR OCTOBER 19, 2011
 
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