Safety
-
Enforcement Report for November 16, 2011
November 16, 2011 11-46
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
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PRODUCT
Plastic container with paper label, labeled in part:"Publix DELI spinach dip***with spinach, sour cream, water chestnuts, and onions Keep refrigerated. Container is not microwaveable. Net wt. 16 oz (1 lb) 454g***." Recall # F-0024-2012
CODE
use by date of OCT 10 C1
RECALLING FIRM/MANUFACTURER
Publix Super Markets, Inc., Lakeland, FL, by letter on September 26, 2011. Firm initiated recall is ongoing.
REASON
Product may have been adulterated with Listeria monocytogenes. Consumption of products containing Listeria monocytogenes can cause serious and sometimes fatal infection in young children, frail or elderly people, and others with weakened immune systems.
VOLUME OF PRODUCT IN COMMERCE
59 units
DISTRIBUTION
FL, SC
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PRODUCT
There is no product labeling for Fresh Hot Basil. Product was shipped as 10 lb bundles in reused cardboard banana boxes that were lined with newspapers. Labeling on shipping container: Air Waybill from Southwest airlines (526 1864 9864). Recall # F-1893-2011
CODE
Ship dates of 08/23/11 and 08/30/11
RECALLING FIRM/MANUFACTURERO
Sanith Ourn dba Asiana Harvest, Indiantown, FL, by telephone on September 2, 2011 and letter on September 8, 2011. FDA initiated recall is ongoing.
REASON
Sanith Ourn dba Asiana Harvest initiated a recall of Fresh Hot Basil after FDA laboratory analysis detected the presence of salmonella.
VOLUME OF PRODUCT IN COMMERCE
390 lbs
DISTRIBUTION
RI, WA, OR
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PRODUCT
Frontera Produce Rocky Ford Cantaloupes. The recalled cantaloupes were shipped in cardboard cartons which resembled a color print showing cantaloupes contained within a wooden pallet. Additional labeling on the outer carton included "Colorado Proud Frontera Produce”. Individual cantaloupes are identified with a green and white sticker that reads: Product .of USA- Frontera Produce-Colorado Fresh-Rocky Ford-Cantaloupe or a Grey, Yellow, and Green sticker that reads: Jensen Farms-Sweet Rocky Ford; the cantaloupe may also contain no label at all. Recall # F-1894-2011
CODE
All product shipped between July 29 and Sept 10, 2011.
RECALLING FIRM/MANUFACTURER
Jensen Farms, Holly, CO, by telephone or e-mail on September 12, 2011. FDA initiated recall is ongoing.
REASON
Whole cantaloupes may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
310,032 approximately 40 lb cartons of cantaloupes
DISTRIBUTION
Nationwide
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PRODUCT
Supreme Protein Chocolate Caramel Cookie Crunch .71 oz (20 g) UPC 639372022909 Serving Size 1 bar (20 g); UPC 639372022602. Recall # F-0122-2012
CODE
Lot B11272A October 2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Supreme Protein, Manasquan, NJ, by e-mail, letter and telephone on October 11, 2011.
Manufacturer: Belmont Confections Inc., Youngstown, OH. Firm initiated recall is ongoing.
REASON
Product may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
473 bars
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Bapehuku Dupling brand Vareniki - cabbage, Net wt. 14 oz, UPC 7 07163 02619 8. The product is distributed frozen in sealed plastic bags. Recall # F-0027-2012;
2) Bapehuku Dupling brand Vareniki - potato & onion, Net wt. 14 oz, UPC 7 0 7163 02616 7. The product is distributed frozen in sealed plastic bags. Recall # F-0028-2012;
3) Bapehuku Dupling brand Vareniki - potato & mushroom, Net wt. 14 oz, UPC 7 07163 02617 4. The product is distributed frozen in sealed plastic bags. Recall # F-0029-2012;
4) Bapehuku Dupling brand Vareniki - farmer cheese, NET WT. 14 oz, UPC 7 0716 302618 1. The product is distributed frozen in sealed plastic bags. Recall # F-0030-2012;
5) Bapehuku Dupling brand Vareniki - sour cherry, Net wt. 14 oz, UPC 7 07163 02615 0. The product is distributed frozen in sealed plastic bags. Recall # F-0031-2012;
CODE
"BEST BEFORE SEP 19 2011" through "BEST BEFORE MAR 19 2012"
RECALLING FIRM/MANUFACTURER
M & P Food Productions, Ltd., Brooklyn, NY, by telephone on September 21, 2011 and press release on September 23, 2011.
REASON
The product contains undeclared milk and wheat based on FDA's findings.
VOLUME OF PRODUCT IN COMMERCE
3,276 units (total for 5 products)
DISTRIBUTION
NY, CT, MA, OH, PA, FL, NJ, NC, SC
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
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PRODUCT
Sexual Virility Max (Bulk drug product)
CODE
Lot 10090571, Product code 30535-B01
RECALLING/MANUFACTURING FIRM
Recalling Firm: ABCO Laboratories, Inc., Fairfield, CA
Manufacturing Firm: ABCO Laboratories, Inc. Fairfield, CA
REASON FOR RECALL
Marketed without an approved NDA/ANDA: FDA lab analysis found the product to contain sulfoaildenafil and sulfosildenafil, analogues of sildenafil, the active ingredient in a FDA approved drug used to treat erectile dysfunction (ED), making this product an unapproved new drug.
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PRODUCT
1) Rite Aid Pharmacy, Laxative Saline Enema, 4.5 fl oz bottles, NDC 11822-4890-80 ---- Also labeled as Premier Value, Complete Ready to Use Enema, 4.5 fl oz bottles NDC #68016-0021-45
CODE
Lot 2021, Expiration date: 07/2013
RECALLING/MANUFACTURING FIRM:
Recalling Firm: Natureplex Llc, Memphis TN
Manufacturing Firm: Natureplex Llc, Memphis, TN 38118
REASON FOR RECALL
CGMP Deviations: out of specification results for specific gravity and phosphate content. The USP assay for phosphate, based on titration, led to method variability.
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
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 ongoing.
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) Quetiapine Fumarate, 100 MG, Tablet, NDC 00310-0271-10. Recall # D-384-2012;
2) Quetiapine Fumarate, 25 MG, Tablet, NDC 00310-0275-10. Recall # D-385-2012;
3) Quetiapine Fumarate, 300 MG,Tablet, NDC 00310-0274-60. Recall # D-386-2012;
4) Quinapril HCL, 10 MG, Tablet, NDC 59762-5020-01. Recall # D-387-2012;
5) Quninapril HCL, 20 MG, Tablet, NDC 00071-0532-23, 59762-5021-01. Recall # D-388-2012;
6) Quninapril HCL, 40 MG, Tablet, NDC 59762-5022-01. Recall # D-389-2012;
7) Quinapril HCL, 5 MG, Tablet, NDC 59762-5019-01. Recall # D-390-2012;
8) Quinidine Sulfate, 200 MG, Tablet, NDC 00185-4346-01, 53489-0461-01. Recall # D-391-2012;
9) Quinidine Sulfate, 300 MG, Tablet, NDC 00093-9175-01. Recall # D-392-2012;
10) Quinine Sulfate, 324 MG, Caplet, NDC 13310-0153-07. Recall # D-393-2012;
11) Raloxifene HCL, 60 MG, Tablet, NDC 00002-4165-02, 00002-4165-30. Recall # D-394-2012;
12) Raltegravir, 400 MG Tablet, NDC 00006-0227-61. Recall # D-395-2012;
13) Ramipril, 10 MG, Caplet, NDC 00054-0109-25. Recall # D-396-2012;
14) Ranexa, 500 MG Tablet, NDC 06195-8100-11. Recall # D-397-2012;
15) Ranitidine, 150 MG, Tablet, NDC 00172-4357-49, 68462-0248-01, 68462-0248-05. Recall # D-398-2012:
16) Ranitidine, 75 MG, Tablet, NDC 00904-5818-46, 00904-5818-52. Recall # D-399-2012;
17) Ranolazine ER, 500 MG Tablet, NDC 61958-1001-01. Recall D-400-2012;
18) Rasagiline, 0.5 MG, Tablet, NDC 68546-0142-56. Recall # D-401-2012;
19) Rasagiline, 1MG, Tablet, NDC 68546-0229-56. Recall # D-402-2012;
20) Rena-Vite RX, Tablet, NDC 60258-0161-01. Recall # D-403-2012;
21) Rena-Vite, Tablet, NDC 60258-0160-01. Recall # D-404-2012;
22) Repaglinide, 0.5 MG, Tablet, NDC 00169-0081-81. Recall # D-405-2012;
23) Repaglinide, 1 MG, Tablet, NDC 00169-0082-81. Recall # D-406-2012;
24) Repaglinide, 2 MG, Tablet, NDC 00169-0084-81. Recall # D-407-2012;
25) Reserpine, 800 MG, Tablet, NDC 00185-0032-01. Recall # D-408-2012;
26) Reyataz, 100MG, Caplet, NDC 00003-3623-12. Recall # D-409-2012;
27) Ribavirin, 200 MG, Tablet, NDC 00781-5177-28. Recall # D-410-2012;
28) Riboflavin, 100 MG, Tablet, NDC 11845-0171-41, 3292-0560-00. Recall # D-411-2012;
29) Rifabutin, 150 MG, Caplet, NDC 00013-5301-17. Recall # D-412-2012;
30) Rifampin, 150 MG, Caplet, NDC 00185-0801-01, 00185-0801-30. Recall # D-413-2012;
31) Rifampin, 300 MG, Caplet, NDC 61748-0018-30, 61748-0018-60. Recall # D-414-2012;
32) Rifaximin, 200 MG, Tablet, NDC 65649-0301-03, 65649-0301-41. Recall # D-415-2012;
33) Riluzole, 50 MG, Tablet, NDC 00075-7700-60. Recall # D-416-2012
34) Rimantadine HCL, 100 MG, Tablet, NDC 00115-1911-01. Recall # D-417-2012;
35) Risedronate Sodium, 35 MG, Tablet, NDC 00149-0472-01. Recall # D-418-2012;
36) Risedronate Sodium, 5 MG, Tablet, NDC 00149-0471-01. Recall # D-419-2012;
37) Risedrontate Sodium, 30 MG, Tablet, NDC 00149-0470-01. Recall # D-420-2012;
38) Risperidone, 1 MG, Tablet, NDC 50458-0592-60. Recall # D-421-2012;
39) Risperidone, 1 MG/ML Solution, NDC 50458-0596-01, 60505-0380-01. Recall # D-422-2012;
40) Risperidone, 2 MG, Tablet, NDC 00093-7241-06. Recall # D-423-2012;
41) Risperidone, 3 MG, Tablet, NDC 50458-0594-60. Recall #: D-424-2012;
42) Risperidone, 4 MG, Tablet, NDC 64679-0572-04. Recall #: D-425-2012;
43) Ritonavir, 100 MG, Caplet, NDC 00074-6633-30. Recall # D-426-2012;
44) Ritonavir, 100 MG, Tablet, NDC 00074-3333-30. Recall # D-427-2012;
45) Risedrontate Sodium, 30 MG, Tablet, NDC 00149-0470-01. Rivastigmine Tartrate, 1.5 MG, Caplet, NDC 00078-0323-44, 00781-2614-60. Recall # D-428-2012;
46) Rivastigmine Tartrate, 4.5 MG, Caplet, NDC 00078-0325-44. Recall # D-429-2012;
47) Ropinirole HCI, 0.5 MG, Tablet, NDC 00378-5550-01. Recall # D-430-2012;
48) Ropinirole HCL, 0.25 MG, Tablet, NDC 00054-0116-25, 64720-0201-10, 68462-0253-01. Recall # D-431-2012;
49) Ropinirole HCL, 1 MG, Tablet, NDC 64679-0171-02. Recall # D-432-2012;
50) Ropinirole HCL, 2 MG, Tablet, 00054-0119-25, 00093-5285-01. Recall # D-433-2012;
51) Rosiglitazone Maleate, 2 MG, Tablet, NDC 00029-2158-18, 00029-3158-18.
Recall # D-434-2012;
52) Rosiglitazone Maleate, 4 MG, Tablet, NDC 00029-3159-00, 00029-3159-13. Recall # D-435-2012;
53) Rosuvastatin Calcium, 10 MG, Tablet, NDC 00310-0751-90. Recall # D-436-2012;
54) Rosuvastatin Calcium, 5 MG, Tablet, NDC 00310-0755-90. Recall # D-437-2012;
55) Saccharomyces Boulardll LYO, 250 MG, Caplet, NDC 04142-0000-07, 66825-0002-01. Recall # D-438-2012;
56) Salsalate, 500 MG, Tablet, NDC 65162-0512-10. Recall # D-439-2012;
57) Salsalate, 750 MG, Tablet, NDC 65162-0513-10; 65162-0513-11; 68462-0103-40.
Recall # D-440-2012;
58) Saquinavir Mesylate, 200 MG, Caplet, NDC 00004-0245-15. Recall # D-441-2012;
59) Selegiline HCL, 5 MG Caplet, NDC 62753-0700-06. Recall # D-442-2012;
60) Selenium, 100 MCG, Tablet, NDC 30768-0004-86. Recall # D-443-2012;
61) Selenium 200 MCG Tablet, NDC 00904-4203-52, 54629-0163-00, 74312-0032-01, 79854-0011-63. Recall # D-444-2012;
62) Sennosides, 17.6, MG/10 ML, NDC 00536-1275-59. Recall # D-445-2012;
63) Sennosides, 8.6 MG, Tablet, NDC 00182-1093-01, 00182-1093-10, 00603-0282-21, 00603-0282-32, 00904-5165-59, 00904-5165-80, 49348-0262-10, 51645-0851-01, 51645-0851-10. Recall # D-446-2012;
64) Sennosides, 8.8 MG/5 ML, Liquid, NDC 00536-1275-59, 00904-6206-09, 57896-0452-08. Recall # D-447-2012;
65) Sennosides/Docusate Sodium, 8.6/50 MG, Tablet, NDC 00904-5512-80. Recall # D-448-2012;
66) Sertraline HCL, 100 MG, Tablet, NDC 00143-9580-09. Recall # D-449-2012;
67) Sertraline HCL, 20 MG/ML, Concentrate, NDC 59762-4940-01. Recall # D-450-2012;
68) Sevelamer Carbonate, 800 MG, Tablet, NDC 58468-0130-01. Recall # D-451-2012;
69) Sevelamer HCL, 400 MG, Tablet, NDC 58468-0020-01. Recall # D-452-2012;
70) Sevelamer HCL, 800 MG, Tablet, NDC 58468-0021-01. Recall # D-453-2012;
71) Sildenafil, 20 MG, Tablet, NDC 00069-4190-68. Recall # D-454-2012;
72) Sildenafil Citrate, 25 MG, Tablet, NDC 00069-4200-30. Recall # D-455-2012:
73) Sildenafil Citrate, 50 MG, Tablet, NDC 00069-4210-30, 00069-4210-66. Recall # D-456-2012;
74) Simethicone, 20 MG/0.3 ML, Suspension, NDC 00904-5894-30, 50383-0785-30. Recall # D-457-2012;
75) Simethicone Oral Suspension, 20 MG/0.3 ML, NDC 00603-0894-50. Recall # D-458-2012;
76) Simvastatin, 10 MG, Tablet, NDC 68180-0478-02. Recall # D-459-2012;
77) Simvastatin, 20 MG, Tablet, NDC 68180-0479-03. Recall # D-460-2012;
78) Simvastatin, 40 MG, Tablet, NDC 16729-0006-15, 68180-0480-03. Recall # D-461-2012;
79) Simvastatin, 80 MG, Tablets, NDC 68180-0481-03. Recall # D-462-2012;
80) Sitagliptin, 100 MG, Tablet, NDC 00006-0277-31, 00006-0277-54. Recall # D-463-2012;
81) Sitagliptin, 25 MG, Tablet, NDC 00006-0221-31, 00006-0221-54. Recall # D-464-2012;
82) Sitagliptin, 50 MG, Tablet, NDC 00006-0112-31. Recall # D-465-2012;
83) Sodium Bicarbonate, 325 MG (5GR), Tablet, NDC 00536-4540-10. Recall # D-466-2012;
84) Sodium Bicarbonate, 650 MG, Tablet, NDC 00536-4544-10. Recall # D-467-2012;
85) Sodium Chloride, 1G (15.4 GR), Tablet, NDC 00023-1760-02, 00223-1760-01; 00223-1760-02; 00527-1116-10. Recall # D-468-2012;
86) Sodium Citrate/Citric Acid Oral Solution, 500/334 MG Per 5 ML, Unit, NDC 60258-0001-16. Recall # D-469-2012;
87) Sodium Fluoride, 0.5 MG, Chewable Tablet, NDC 60258-0156-20. Recall # D-470-2012;
88) Sodium Fluoride, 1 MG, Tablet, NDC 60258-0157-20. Recall # D-471-2012;
89) Solifenacin Succinate, 5 MG, Tablet, NDC 51248-0150-01, 51248-0150-03. Recall # D-472-2012;
90) Sorbitol Solution, USP 70% W/W, Unit, NDC 00121-0659-16. Recall # D-473-2012;
91) Sotalol HCL, 120 MG, Tablet, NDC 00093-1060-01. Recall # D-474-2012;
92) Sotalol HCL, 80 MG, Tablet, NDC 00093-1061-01, 00185-0171-01. Recall # D-475-2012;
93) Spironolactone, 25 MG, Tablet, NDC 00228-2803-11. Recall # D-476-2012;
94) Stavudine, 20 MG, Caplet, NDC 00378-5041-91, 65862-0112-60. Recall # D-477-2012;
95) Stavudine, 40 MG, Caplet, NDC 00378-5043-91. Recall # D-478-2012;
96) Sucralfate, 1 GM, Tablet, NDC 00093-2210-05; 00591-0780-01; 00591-0780-05; 29033-0003-01; 29033-0003-05. Recall # D-479-2012;
97) Sular, 25.5 MG, Tablet, NDC 59630-0502-10. Recall # D-480-2012;
98) Sulfa & Trim DS, 800/160 MG, Tablet, NDC 00603-5781-21, 00904-2725-40, 51079-0128-20. Recall # D-481-2012;
99) Sulfa/Trim 400/80 MG, Tablet, NDC 53489-0145-01. Recall # D-482-2012;
100) Sulfadiazine, 500 MG, Tablet, NDC 00185-0757-01. Recall # D-483-2012;
101) Sulfamethoxazole/Trimethoprim 400/80 MG, Tablet, NDC 00603-5780-21, 53746-0271-01. Recall # D-484-2012;
102) Sulfamethoxazole/Trimethoprim DS, 800/160 MG, Tablet, NDC 53746-0272-01, 53746-0272-05. Recall # D-485-2012;
103) Sulfamethoxazole/Trimethoprim Oral Susp, 200/40 MG 5 ML, Unit, NDC 50383-0823-16, 50383-0824-16. Recall # D-486-2012;
104) Sulfasalazine, 500 MG, Tablet, NDC 00591-0796-01, 00904-1152-40, 59762-5000-01. Recall # D-487-2012;
105) Sulindac, 150 MG, Tablet, NDC 00591-5661-01, 23155-0005-01. Recall # D-488-2012;
106) Sulindac, 200 MG, Tablet, NDC 42806-0011-01. Recall # D-489-2012;
107) Sumatriptan Succinate, 25 MG, Tablet, NDC 00378-5630-59. Recall # D-490-2012;
108) Sunitinib Malate, 12.5 MG, Caplet, NDC 00069-0550-38. Recall # D-491-2012;
109) Sunitinib Malate, 25 MG, Caplet, NDC 00069-0770-38. Recall D-492-2012;
110) Super B Complex W/C, Caplets, NDC 54629-0080-01. Recall # D-493-2012
CODE
1) Lot: WC0127, Exp 06/07/11;
2) Lot: WC0076, Exp 10/11/11; WM0036, Exp 10/11/11;
3) Lot: WL0051, Exp 09/22/11;
4) Lot: V092291, Exp 08/05/11; V100720, Exp 07/30/11, 03/14/12; V101393, Exp 01/05/12; V101394, Exp 01/28/12, 02/15/12; V101746, Exp 03/31/12; V101747, Exp 04/24/12, 05/01/12, 05/04/12;
5) Lot: V091948, Exp 07/23/11; V101097, Exp 09/30/11; V101192, Exp 11/12/11; V101562, Exp 12/28/11; V101564, Exp 04/11/12; V101666, Exp 05/09/12;
6) Lot: V101589, Exp 03/17/12;
7) Lot: V092155, Exp 01/06/12; V101476 Exp 05/04/12;
8) Lot: ME080373, Exp 05/17/12; 62321, Exp 10/31/11;
9) Lot: 30208655A, Exp 11/30/11;
10) Lot: 62472, Exp 05/27/11; 62564, Exp 07/29/11; 62565, Exp 11/10/11; 63262, 04/12/12;
11) Lot: A693843A, Exp 07/01/11; A699380A, Exp 06/23/11; A755320A, Exp 10/26/11; A808368A, Exp 03/02/12; A808369A, Exp 03/01/12; A821372, Exp 04/17/12; A821408A, Exp 05/12/12; A728537A, Exp 09/21/11; A729715A, Exp 07/27/11; A732505A, Exp 08/17/11; A748196A, Exp 09/15/11; A750632A, Exp 10/11/11; A795066A, Exp 12/06/11; A798438A, Exp 02/11/12; A803423A, Exp 01/25/12, 01/26/12; A803424A, Exp 02/22/12, 02/24/12; A804596A, Exp 04/06/12, 04/27/12; A821375A, Exp 04/17/12;
12) Lot: E011134, Exp 02/18/12; G000656, Exp 04/17/12;
13) Lot: 059966B, Exp 03/02/12, Exp 05/03/12, Exp 05/11/12;
14) Lot: 02008246, Exp 11/17/11;
15) Lot: TE0X004, Exp 05/04/12; RNGMA 9078, Exp 11/30/11; 10AN51A, Exp 08/26/11; 10AN58A, Exp 09/07/11, 09/20/11; 10AN60A, Exp 08/16/11; 1OAN 60A, Exp 09/15/11;
16) Lot: 0KE2134, Exp 03/01/12; 0FE1821, Exp 08/19/11; 0KE1729, Exp 03/01/12; OFE1821, Exp 07/21/11; OME1152, Exp 01/20/12;
17) Lot: 02007365, Exp 02/11/12; 2007640, Exp 06/08/11; 2007641, Exp 07/13/11; 2007642, Exp 08/11/11; 02008541, Exp 12/07/11, 12/10/11; 02008542, Exp 12/29/11; 02008659, Exp 01/11/12; 02008660, Exp 02/14/12; 02008661, Exp 02/22/12, 03/15/12; 02008769, Exp 02/24/12; 02008770, Exp 04/14/12, 04/27/12; 02009092, Exp 04/14/12; 02009110, Exp 04/17/12; 02009111, Exp 04/18/12; 02009323, Exp 05/17/12; 02009325, Exp 05/16/12; 2790748, Exp 03/15/12, 03/22/12, 05/03/12; 2895430, Exp 03/06/12, 03/27/12, 03/30/12; 2895431, Exp 04/10/12; 2895432, Exp 03/06/12; '02007361, Exp 06/22/11; '02007642, Exp 07/26/11; O2008246, Exp 11/19/11; O2008540, Exp 11/23/11;
18) Lot: R15014, Exp 05/09/12;
19) Lot: R14226, Exp 05/09/12;
20) Lot: 94250, Exp 05/28/11; 101277, Exp 05/28/11; 101645, Exp 08/05/11; 104515, Exp 04/18/12;
21) Lot: 101390, Exp 08/06/11, 08/16/11; 102355, Exp 10/26/11, 11/08/11, 11/17/11, 11/22/11, 12/08/11, 12/15/11, 12/17/11, 05/12/12; 103321, Exp 01/11/12, 01/13/12, 01/26/12, 02/01/12, 02/15/12, 02/17/12, 02/29/12, 03/13/12, 03/15/12; 104123, Exp 03/06/12, 03/31/12, 04/06/12, 04/18/12, 04/21/12, 04/27/12, 05/04/12; 104515, Exp 04/17/12;
22) Lot: 002048E, Exp 12/29/11; 002050A, Exp 04/10/12; 807901E, Exp 12/29/11; 904259E, Exp 10/13/11; O02048C, Exp 11/19/11;
23) Lot: 002793A, Exp 12/29/11, Exp 03/07/12; 906457A, Exp 02/22/12; 906457E, Exp 11/18/11; 909273B, Exp 02/17/12, 03/02/12, 03/15/12, 04/19/12; 909274A, Exp12/02/11;
24) Lot: 005330, Exp 01/07/12, 02/29/12, 03/15/12; 002914A, Exp 11/18/11; '002914A, Exp 10/26/11; 005790A, Exp 02/29/12, 03/15/12; 005790C, Exp 05/05/12; 006943E, Exp 05/15/12; 906452A, Exp 07/14/11;
25) Lot: ME091323, Exp 04/18/12;
26) Lot: 9H3134A, Exp 07/28/11;
27) Lot: 201243, Exp 10/11/11, 11/19/11; 201244, Exp 12/21/11; V09069, Exp 08/13/11; VO9069, Exp 08/30/11;
28) Lot: 8578J, Exp 09/13/11; 340470, Exp 11/04/11;
29) Lot: G481B, Exp 10/31/11; M002D, Exp 08/16/11; M383V, Exp 10/07/11; N099A, Exp 11/11/11; N281F, Exp 03/10/12, 03/30/12, 04/04/12;
30) Lot: ME100276, Exp 01/04/12; ME100825, Exp 03/01/12; ME101075, Exp 04/27/12; ME110004, Exp 04/27/12;
31) Lot: 67914A, Exp 04/13/12; 68441A, Exp 05/10/12;
32) Lot: C9D20051, Exp 09/24/11; C9H22801, Exp 02/17/12; DDWT, Exp 04/19/12;
33) Lot: 8051594, Exp 07/22/11;
34) Lot: H9070021, Exp 06/30/11;
35)Lot: 329254, Exp 06/07/11; 329256, Exp 10/08/11; 329259, Exp 04/24/12; 329261, Exp 03/28/12; 442388, Exp 11/30/11; CN 329254, Exp 06/04/11;
36) Lot: 441653, Exp 01/04/12; 442388, Exp 10/13/11; 443569, Exp 04/21/12, 04/26/12, 05/15/12; CN 441653, Exp 06/03/11;
37) Lot: 441654, Exp 10/13/11; 442654, Exp 04/24/12;
38) Lot: 0KG102, Exp 11/03/11;
39) Lot: AJB4B00, Exp 03/23/12, 04/03/12; JN6508, Exp 04/18/12, 04/19/12, 04/27/12, 05/05/12;
40) Lot: 05R006, Exp 08/31/11;
41) Lot: 1AG427, Exp 04/06/12
42) Lot: DJ11182, Exp 08/30/11;
43) Lot: 857002E21, Exp 06/02/11; 857202E21, Exp 06/22/11; 879552E21, Exp 08/30/11; 879582E21, Exp 07/22/11; 879722E21, Exp 11/01/11, 11/03/11; 903482E21, Exp 01/03/12; 936752E21, Exp 03/08/12; 947452E21, Exp 04/27/12; 936712E22, Exp 02/11/12;
44) Lot: 823012E21, Exp 09/02/11; 891162E21, Exp 11/17/11; 903702E21, Exp 01/18/12; 915422E21, Exp 02/28/12; 010832E, Exp 04/10/12; 010842E, Exp 04/17/12;
45) Lot: 823012E21, Exp 09/02/11; 891162E21, Exp 11/17/11; 903702E21, Exp 01/18/12; 915422E21, Exp 02/28/12; 010832E, Exp 04/10/12; 010842E, Exp 04/17/12;
46) Lot: F4133, Exp 01/11/12; F4137, Exp 07/14/11, 08/11/11; F4138, Exp 11/30/11; F4139, Exp 10/22/11, 11/19/11, 12/10/11, 12/28/11, 01/25/12, 02/09/12, 02/15/12, 03/28/12, 05/02/12; F0002, Exp 03/23/12, 04/17/12;
47) Lot: F0034, Exp 04/12/12;
48) Lot: 060800A, Exp 04/14/12; 105557, Exp 12/08/11, 01/07/12, 02/08/12; 105558, Exp 02/22/12; 02110679, Exp 04/12/12;
49) Lot: DJ11002, Exp 08/03/11; DK11001, Exp 11/19/11; DK11519, Exp 02/15/12;
50) Lot: 060801A, Exp 03/17/12, 04/10/12; 30211446A, Exp 04/10/12;
51) Lot: 0ZP5205, Exp 04/27/12, 05/01/12; 0ZP2844, Exp 01/20/12; 0ZP5205, Exp 05/01/12; 0ZP6142, Exp 08/06/11; 0ZP8017, Exp 11/22/11, 11/30/11, 12/13/11; OZP0201, Exp 07/02/11; OZP8017, Exp 10/31/11;
52) Lot: 0ZP2153, Exp 06/24/11; OZP2153, Exp 06/16/11; 0ZP7644, Exp 11/24/11; 0ZP9900, Exp 12/01/11, 01/12/12, 01/17/12; 1ZP9295, Exp 04/14/12; OZP6141, Exp 09/02/11;
53) Lot: 114138, Exp 03/14/12;
54) Lot: 112928, Exp 10/21/11; 113124, Exp 12/30/11; 113125, Exp 02/11/12; 113144, Exp 03/06/12, 03/13/12; 113145, Exp 03/22/12, 04/06/12; 113379, Exp 03/10/12, 03/24/12, 05/03/12; 113461, Exp 05/04/12; 113591, Exp 04/28/12; 113805, Exp 02/29/12; 114212, Exp 04/13/12, 04/21/12;
55) Lot: 563, Exp 06/03/11; 564, Exp 06/24/11; 561A, Exp 06/03/11; 575B, Exp 11/16/11; 577, Exp 01/07/12; 581, Exp 02/21/12; 583, Exp 03/16/12; 585, Exp 03/16/12, 04/13/12; 586, Exp 03/20/12; 587, Exp 03/24/12; 588, Exp 04/07/12, 04/13/12; 589, Exp 04/25/12, 04/27/12, 05/02/12, 05/05/12; 592, Exp 05/05/12, 05/10/12, 05/12/12; 575B, Exp 12/21/11;
56) Lot: 5120036A, Exp 11/24/11; 5120041A, Exp 01/18/12; 5129026C, Exp 08/03/11;
57) Lot: 5130013C, Exp 06/16/11; 5130055A, Exp 11/05/11; 5130063A, Exp 12/30/11; 5130064A, Exp 12/30/11, 01/03/12; 5130084a, Exp 02/03/12; 5130087A, Exp 02/24/12, 03/23/12; 5131005A, Exp 03/27/12; 5131006A, Exp 04/28/12, 05/03/12, 05/08/12; 5131009A, Exp 04/27/12; 5130002M, Exp 06/07/11; 5130025C, Exp 06/30/11, 07/28/11, 09/02/11; 5130048A, Exp 12/02/11; 5130052A, Exp 01/28/12;
58) Lot: B1265-50, Exp 02/28/12;
59) Lot: 10H052, Exp 01/04/12, 01/11/12; 10C029, Exp 11/08/11; 10L062, Exp 03/28/12; 11B027, Exp 04/24/12;
60) Lot: 22133001, Exp 11/18/11; 304588-02, Exp 02/11/12;
61) Lot: 27312802, Exp 07/23/11; 9LB92, Exp 06/10/11; 291743-02, Exp 03/28/12; 9LB92, Exp 09/07/11, 09/16/11;
62) Lot: 10185, Exp 05/15/12; 11046, Exp 05/15/12;
63) Lot: 89D011W, Exp 01/17/12; 89F018W, Exp 02/10/12, 03/21/12; 89E026W, Exp 02/29/12; 89F019W, Exp 04/19/12; 0D21717, Exp 10/29/11; 0D21715, Exp 01/18/12; J035W, Exp 01/26/12, 01/28/12; K010W, Exp 04/10/12; E025W, Exp 01/28/12; H004W, Exp 01/26/12; X04451, Exp 02/17/12; X05211, Exp 02/11/12; 33571, Exp 01/25/12, 01/26/12, 02/02/12, 01/13/12, 01/26/12, 02/07/12, 02/11/12; 33713, Exp 02/16/12;
64) Lot: 10144, Exp 05/28/11, 06/08/11; 10185, Exp 06/04/11, 06/22/11; 10245, Exp 07/30/11; 10246, Exp 08/27/11, 12/07/11; 10310, Exp 11/24/11, 02/11/12, 02/14/12, 03/01/12; 10449, Exp 03/01/12; 10472, Exp 03/29/12, 04/04/12, 04/06/12, 04/10/12, 04/12/12; 11046, Exp 05/19/12; 100907, Exp 05/09/12; 10277, Exp 11/26/11; 10313, Exp 11/26/11;
65) Lot: 101090, Exp 10/28/11;
66) Lot: I0906385B, Exp 07/08/11, 09/22/11;
67) Lot: 0BFMJ, Exp 03/23/12;
68) Lot: B0001B01, Exp 12/13/11; B0035B01, Exp 07/01/11; B0042B01, Exp 07/01/11, 07/26/11; B0047B01, Exp 07/26/11; B0098B01, Exp 08/05/11; B0116B01, Exp 08/27/11; B0170B01, Exp 10/21/11; B0183B01, Exp 11/08/11, 11/11/11; B0206B01, Exp 11/23/11, 11/30/11, 12/06/11; B0234B01, Exp 12/30/11; B0308B01, Exp 01/25/12, 01/26/12, 04/13/12; B0315B01, Exp 01/11/12; B0368B02, Exp 02/14/12, 02/16/12, 02/17/12, 02/22/12; B0372B01, Exp 03/29/12, 04/10/12; B0455B01, Exp 04/14/12, 04/18/12; B0465B02, Exp 05/17/12, 05/19/12; B0476B01, Exp 04/24/12; B0502B01, Exp 05/16/12; D0022B01, Exp 09/09/11, 09/28/11; D0054B01, Exp 10/11/11; D0069B01, Exp 01/07/12, 01/13/12; D0109B01, Exp 02/01/12; D0114B01, Exp 02/11/12; D0126B01, Exp 03/01/12, 03/07/12, 03/09/12; D0128B01, Exp 03/14/12, 03/15/12; D0131B01, Exp 03/28/12; D0149B01, Exp 05/01/12, 05/08/12, 05/12/12; D0165B01, Exp 04/11/12;
69) Lot: B0012B01, Exp 09/30/11, 03/14/12; B0393B01, Exp 05/15/12, 05/17/12; B9258B01, Exp 09/30/11; D9085B02, Exp 09/30/11;
70) Lot: B0256B01, Exp 05/17/12, 05/18/12; B0273B01, Exp 12/27/11, 01/07/12; B0352B01, Exp 03/06/12, 05/10/12; B0360B01, Exp 04/13/12, 04/18/12; B0429B02, Exp 03/06/12, 03/09/12, 03/30/12, 03/31/12, 04/03/12, 04/12/12; B9382B02, Exp 06/09/11; B9432B01, Exp 07/26/11; B9508B01, Exp 10/11/11; BO394B01, Exp 03/13/12, 03/16/12, 03/23/12; D0001B02, Exp 11/04/11, 11/08/11, 11/16/11, 11/23/11, 12/08/11; D0052B01, Exp 12/09/11; D0070B01, Exp 01/12/12, 01/18/12, 02/01/12, 02/16/12, 03/14/12; D0173B01, Exp 03/13/12; D0175B01, Exp 03/29/12, 03/31/12, 04/18/12, 04/26/12, 04/27/12; D0178B01, Exp 04/17/12, 04/24/12, 05/04/12; D9075B03, Exp 07/16/11, 07/20/11; D9081B01, Exp 08/17/11; D9085B02, Exp 08/25/11, 08/27/11; D9091B01, Exp 09/30/11; D9110B01, Exp 12/08/11; D9137B01, Exp 10/28/11, 10/31/11;
71) Lot: 0702301, Exp 03/29/12; 736901, Exp 06/25/11, 07/01/11, 07/08/11, 07/09/11; 751702, Exp 09/24/11; 764702, Exp 10/21/11; 0764702, Exp 11/08/11; 0765001, Exp 11/18/11; 0813102, Exp 02/18/12, 03/13/12; 0832501, Exp 03/28/12, 03/31/12, 04/12/12; '0764801, Exp 08/30/11, 09/23/11; A002901, Exp 04/27/12;
72) Lot: 0737101, Exp 11/24/11, 12/03/11; 0803303, Exp 03/08/12, 04/21/12; 9163753, Exp 07/01/11, 07/28/11; '0737101, Exp 08/23/11, 09/10/11, 09/23/11;
73) Lot: 0833401, Exp 05/12/12; 0845701, Exp 05/19/12; 814401, Exp 04/27/12; 814402, Exp 05/08/12;
74) Lot: JBD003, Exp 06/30/11; JBD005, Exp 10/15/11, 10/29/11; JBD008, Exp 03/29/12; JBD009, Exp 11/23/11, 12/15/11, 03/13/12; JBD011, Exp 01/19/12; JBD012, Exp 03/10/12; L006A11A, Exp 04/07/12; 606134, Exp 08/31/11;
75) Lot: L106E10A, Exp 09/24/11;
76) Lot: 3102732B, Exp 01/04/12;
77) Lot: 3102890, Exp 11/03/11;
78) Lot: L09623, Exp 04/28/12; 3102390, Exp 09/30/11; 3102393, Exp 09/13/11; 3103547, Exp 11/03/11; 3103677, Exp 10/31/11, 11/29/11; 3105127, Exp 02/02/12; 3110691, Exp 05/09/12; 3110773, Exp 04/04/12
79) Lot: 3101152, Exp 06/07/11; 3101534, Exp 06/30/11; 3101536, Exp 07/28/11; 3102126, Exp 09/02/11; 3103487, Exp 11/18/11; 3103939, Exp 12/08/11;
80) Lot: E010631, Exp 02/10/12; E008722, Exp 10/28/11; Y3539, Exp 06/16/11.
81) Lot: E007966, Exp 10/22/11; E009437, Exp 02/02/12; E009438, Exp 03/30/12; Y2101, Exp 08/27/11; Y3552, Exp 07/01/11; G000608, Exp 05/17/12;
82) Lot: E006766, Exp 10/22/11; E008837, Exp 11/18/11, 11/22/11, 12/06/11, 02/03/12; E009450, Exp 12/28/11, 01/06/12; E011314, Exp 03/01/12, 03/07/12; G001364, Exp 04/11/12;
83) Lot: 10F425, Exp 07/28/11; 10J715, Exp 02/28/12; 10J717, Exp 04/25/12;
84) Lot: 0289 9080, Exp 12/31/11; 10H559, Exp 12/02/11; 10L897, Exp 03/06/12; 11A025, Exp 05/05/12;
85) Lot: 103210, Exp 08/06/11, 06/01/11, 06/25/11, 02/11/12; 104711, Exp 05/12/12; 109511, Exp 05/12/12; 113210, Exp 08/17/11; 118910, Exp 11/05/11; 124410, Exp 11/11/11, 11/18/11; 124610, Exp 12/29/11, 01/04/12, 02/08/12; 125710, Exp 12/30/11, 05/12/12; 136510, Exp 04/21/12, 04/26/12, 05/03/12; 225710, Exp 03/06/12; 103210, Exp 08/17/11, 09/14/11; 124410, Exp 10/15/11, 04/21/12; 134708, Exp 07/15/11; 2009476007, Exp 09/30/11, 10/31/11; 2010227793, Exp 10/31/11, 04/11/12; 2010227794, Exp 03/28/12; 2010308345, Exp 03/13/12, 05/01/12, 05/04/12;
86) Lot: OB29, Exp 11/29/11;
87) Lot: 92304, Exp 10/01/11;
88) Lot: 103488, Exp 01/17/12;
89) Lot: C1000153, Exp 10/22/11; C1000154, Exp 11/11/11, 11/12/11, 11/17/11, 12/08/11; D1000042, Exp 01/17/12; D1000045, Exp 01/06/12, 01/10/12, 01/31/12, 02/02/12, 02/08/12; D1000046, Exp 02/14/12, 02/17/12, 03/10/12; F1000023, Exp 04/19/12; G1000238, Exp 05/12/12, 05/17/12; G1000182, Exp 05/02/12; L0900075, Exp 06/25/11;
90) Lot: 9C86, Exp 11/29/11; 9G48, Exp 12/07/11; 9J12, Exp 11/29/11; OE55, Exp 11/29/11;
91) Lot: 35201719A, Exp 04/25/12;
92) Lot: 35201160A, Exp 08/31/11; 35313140A, Exp 07/22/11; 35316474A, Exp 12/15/11, 12/17/11, 01/20/12; 35317031c, Exp 01/26/12; 35317032C, Exp 03/22/12; 203829, Exp 02/22/12;
93) Lot: 308G01, Exp 11/05/11; 810C11, Exp 05/03/12;
94) Lot: 1028960, Exp 10/13/11, 01/06/12; WR2010001-A, Exp 01/11/12;
95) Lot: 1029494, Exp 11/18/11;
96) Lot: 30214540A, Exp 05/03/12; 1137975, Exp 03/31/12; 1137977, Exp 04/24/12, 05/12/12, 05/17/12; 1136825, Exp 03/30/12; SUC110501, Exp 04/10/12, 04/17/12; SUC110405, Exp 04/18/12;
97) Lot: 2020621, Exp 07/14/11;
98) Lot: T130C10A, Exp 08/19/11, 10/26/11; HA19610, Exp 10/20/11; OH909, Exp 08/05/11;
99) Lot: 62365, Exp 06/10/11; 62366, Exp 08/31/11;
100) Lot: ME090497, Exp 09/24/11; ME100822, Exp 01/06/12;
101) Lot: T052H10A, Exp 12/30/11; HC42510, Exp 06/14/11, 06/29/11; HE17110, Exp 09/30/11; HK07010, Exp 12/15/11; HM44910, Exp 03/31/12; HM45010, Exp 05/17/12;
102) Lot: HA20310, Exp 05/27/11; HH07610, Exp 11/24/11; HC01810, Exp 06/07/11; HC41210, Exp 06/07/11; HD16410, Exp 06/30/11; HE09610, Exp 07/28/11; HE10110, Exp 07/28/11; HE11610, Exp 09/02/11; HE11710, Exp 09/02/11; HG05810, Exp 09/30/11; HH08010, Exp 11/05/11; HK30710, Exp 12/28/11, 12/29/11; HM40810, Exp 02/24/12;
103) Lot: 608521, Exp 03/01/12; 608712, Exp 03/07/12; 609168, Exp 05/04/12; 609263, Exp 04/25/12; 609266, Exp 04/25/12; 604577, Exp 07/27/11; 607175, Exp 11/30/11, 12/21/11; 607729, Exp 02/11/12; 608282, Exp 02/03/12, 02/04/12; 608358, Exp 02/11/12; 650142, Exp 09/15/11;
104) Lot: 3078798, Exp 09/09/11, 09/23/11; 3081421, Exp 09/23/11, 12/08/11, 12/10/11, 12/13/11; 3082716, Exp 12/17/11; 3084040, Exp 03/14/12, 03/31/12; 3084041, Exp 04/18/12; L-2051A, Exp 03/10/12; 5071959A, Exp 01/28/12; 5074978A, Exp 02/29/12; 5075125A, Exp 05/03/12; 5075178A, Exp 05/11/12; 5075304A, Exp 05/11/12;
105) Lot: 329794A, Exp 01/06/12; 6249003, Exp 10/07/11; 6240001B, Exp 02/15/12; 6249003A, Exp 11/19/11; 6420001B, Exp 01/31/12, 03/16/12;
106) Lot: EP090022, Exp 11/30/11;
107) Lot: 3019069, Exp 02/16/12;
108) Lot: N953B, Exp 02/25/12, 02/29/12;
109) Lot: 56189, Exp 02/29/12;
110) Lot: 0EA03, Exp 07/30/11, 09/30/11; 0FB08, Exp 09/30/11; 0HB44, Exp 02/02/12; 1AA37, Exp 04/28/12; 9JA75, Exp 06/18/11; OHA96, Exp 09/30/11
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 and posted on the company's website on June 1, 2011. FDA initiated recall is ongoing.
REASON
There is a potential for Penicillin cross contamination.
VOLUME OF PRODUCT IN COMMERCE
Total 3,524,891 dosage units (238,428 units for drugs Q-S)
DISTRIBUTION
AK, CA, OR, NV, WA
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
CellCept (mycophenolate mofetil) Oral Suspension, 200 mg/mL, 175 mL after constitution in a 225 mL bottle, Rx only, NDC 0004-0261-29, UPC 3 0004-0261-29 5. Recall # D-708-2012
CODE
Lot #: 896992, 896993, 904407, 904408, 905985, 905986, 905987, Exp 02/28/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Genentech Inc., South San Francisco, CA, by letters on June 27, 2011.
Manufacturer: Patheon Inc. - Toronto Region Operations, Mississauga Ontario, Canada. Firm initiated recall is ongoing.
REASON
CGMP Deviations: The Press-In Bottle Adapter (PIBA) does not fit into the CellCept Oral Suspension bottles.
VOLUME OF PRODUCT IN COMMERCE
6,473 bottles
DISTRIBUTION
Nationwide and Puerto Rico
___________________________________
PRODUCT
Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) 0.625 mg/2.5 mg, Rx only, NDC 0046-1107-11. Recall # D-719-2012
CODE
F39318
RECALLING FIRM/MANUFACTURER
Firm: Pfizer Inc., New York, NY, by letter on August 29, 2011.
Manufacturer: Pfizer, Inc., Rouses Point, NY. Firm initiated recall is ongoing.
REASON
Labeling: Label w/Wrong or Incorrect EXP. Date: Expiration date assigned December 2013 instead of December 2012.
VOLUME OF PRODUCT IN COMMERCE
5,358 cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
CETRAXAL(R) (ciprofloxacin otic solution) 0.2%, Sterile, 2 single use containers, 0.25 mL each (deliverable volume), Rx only, NDC 66992-450-02. Recall # D-843-2012
CODE
Lot Numbers: F09019, Exp. 06/2012; G09051, Exp 07/2012; G09052, Exp. 07/2012; G09083, 07/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wraser Pharmaceuticals, Ridgeland, MI, by email/formal letter on September 30, 2011.
Manufacturer: The Ritedose, Corp, Columbia, SC. Firm initiated recall is ongoing.
REASON
Stability data does not meet expiration date; out of specification for osmolality and weight loss.
VOLUME OF PRODUCT IN COMMERCE
799,440 vials
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0064-12
CODE
Unit: LQ49122
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on June 7, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0066-12
CODE
Unit: FN12690
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Chico CA, by telephone and fax on March 19, 2007. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0068-12
CODE
Units: GG26104; GF72751; GF68232
RECALLING FIRM/MANUFACTURERO
Sacramento Medical Foundation, Chico, CA, by telephone on August 23, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0069-12
CODE
Units: R193436
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA,by letter dated October 27, 2005. 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
1) Platelets Pheresis Leukoreduced/P1, Recall # B-0070-12;
2) Platelets Pheresis Leukoreduced Irradiated. Recall # B-0071-12
CODE
1) Unit: 020FR17863;
2) Unit: 020FR18017
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Boise, ID, by fax on February 15, 2006.
Manufacturer: American National Red Cross, Great Falls, MT. Firm initiated recall is complete.
REASON
Blood products, with insufficient plasma to support the platelet concentrations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MT
___________________________________
PRODUCT
Platelets Pheresis Leukoreduced P1. Recall # B-0072-12
CODE
Unit: 20GR22520
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Boise, ID, by letter dated April 28, 2006 a revised letter on May 4, 2006 and June 6, 2006.
Manufacturer: American National Red Cross, Great Falls, MT. Firm initiated recall is complete.
REASON
Blood product, with an unacceptably high platelet yield, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MT
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0073-12
CODE
Unit: GG17169
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Chico, CA, by telephone on February 15, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0074-12
CODE
Unit: 020FR18941
RECALLING FIRM/MANUFACTURERO
Recalling Firm: The American National Red Cross, Boise, ID, by telephone and fax on August 8, 2006.
Manufacturer: Lewis and Clark Region-Montana, Great Falls, MT. Firm initiated recall is complete.
REASON
Blood product, with unacceptably high platelet yield, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MT
___________________________________
PRODUCT
Red Blood Cells Leukoreduced. Recall # B-0117-12
CODE
Units: 020GY26206; 020GY27044
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Boise, ID, by fax on March 31, 2006.
Manufacturer: American National Red Cross, Great Falls, MT. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported living in a malarial endemic country for more than 5 years, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OR, MT
___________________________________
PRODUCT
Haemonetics PCS2 Plasma Collection System includes High Separation Disposable Centrifuge -System for Plasma Aphaeresis Catalog Number: 625HS-00. Recall # B-0122-12
CODE
Lot Numbers: NN08535, SS08511, TT07534, XX09504
RECALLING FIRM/MANUFACTURER
Recalling Firm: Haemonetics Corp., Braintree, MA, by letter on September 8, 2011.
Manufacturer: Haemonetics (UK) Ltd., Bothwell, UK, Firm initiated recall is ongoing.
REASON
Plasma Collection System, with black particulates observed in the collected plasma product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
675 units
DISTRIBUTION
IL, IN, FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0152-12
CODE
Units: LR61436, LQ86910, LQ55245, LQ13401
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Mather, CA, by telephone and facsimile on September 8, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0153-12
CODE
Units: W035808076068 (2 units)
RECALLING FIRM/MANUFACTURERO
BloodSource, Inc., Mather, CA, by telephone and facsimile on September 22, 2008. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly labeled as leukoreduced, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0154-12
CODE
Unit: 7096026 (Bags 1 and 2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, inc-cellular Therapy Laboratory, New York, NY, by telephone on April 19, 2007.
Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Propionibacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0156-12
CODE
Units: C332433, C336435
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by letter dated May 8, 2006.
Manufacturer: Puget Sound Blood Center, Tukwila, WA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0179-12
CODE
Units: W067310022046, W067309023694 (2 units), W067310007021, W067310004666, W067310009434 (2 units), W067310022193
RECALLING FIRM/MANUFACTURERO
Coffee Memorial Blood Center, Amarillo, TX, by letter dated September 7, 2011. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0196-12
CODE
Units: W043211021840; W043210033754
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by fax on September 2, 2011, September 16, 2011 and September 29, 2011. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN, NY, TN
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0199-12;
2) Plasma Frozen within 24 hours (FP24). Recall # B-0200-12
CODE
1) and 2) Unit: W071911002111
RECALLING FIRM/MANUFACTURER
South California Permamente Med Group Blood Donor Center, Los Angeles, CA, by telephone and fax on June 13, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0201-12
CODE
Unit: 004GY12145
RECALLING FIRM/MANUFACTURER
Arc Blood Services, New England Region, Dedham, MA, by fax on August 24, 2011. Firm initiated recall is complete.
REASON
Blood product, positive for the Cw antigen but labeled as Cw antigen negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0203-12;
2) Cryoprecipitated AHF. Recall # B-0204-12
CODE
1), 2) Unit: KK87888
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Chico, CA, by telephone on October 27, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0065-12
CODE
Unit: LQ49122
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on June 7, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma: Recall # B-0067-12
CODE
Units: GG26104; GF72751
RECALLING FIRM/MANUFACTURERO
Sacramento Medical Foundation, Chico, CA, by telephone on August 23, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0075-12
CODE
Units: LQ37723; GG21643; LQ33450
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on May 16, 2007. Firm initiated recall is complete.
REASON
Blood products, for which documentation of temperature was unacceptable, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Recovered Plasma. Recall # Recall # B-0118-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0119-12
CODE
1) and 2) Unit: LS06080
RECALLING FIRM/MANUFACTURERO
BloodSource, Inc., Sacramento, CA, by telephone on April 7, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose arm inspection was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
CA
DISTRIBUTION
2 units
___________________________________
PRODUCT
Fenwal Blood Component Infusion Set with 80 Micron Blood Component Filter and Female Luer, 33 cm (13") long; an Rx sterile fluid pathway with filter for transfusion of blood components; 1 unit per box, 48 boxes per case; Made in Dominican Republic; product 4C2223. Recall # B-0184-12
CODE
Lot numbers: FA09A29206, FA09A30055, FA09B12036, FA09B13034, FA09B19056, FA09B21011, FA09B26200, FA09C30127, FA09D02124, FA09G15038, FA09G17208, FA09H05045, FA09K12020, FA09L11053, FA09L17076, FA09L23199, FA10A29138, FA10B10011, FA10B22016, FA10B22180, FA10C29084, FA10C30082, FA10D05132, FA10D13011, FA10E13034, FA10E18033, FA10F16027, FA10F29053, FA10G16041, FA10L10011, FA11A26018, FA11B23039, FA11C24035, FA11D27200, FA11E16010, FA11E23024, FA11F01028, FA11F02018
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fenwal Inc., Lake Zurich, IL, letters dated October 4, 2011.
Manufacturer: Baxter Fenwal Division, Haina, Dominican Republic. Firm initiated recall is ongoing.
REASON
Blood component infusion set, mislabeled as containing a 80 micron filter, was distributed.
VOLUME OF PRODUCT IN COMMERCE
161,145 sets
DISTRIBUTION
Nationwide, Canada, Columbia, Israel, Singapore and Venezuela
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0197-12
CODE
Units: W043211021840; W043210033754
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by fax on September 2, 2011, September 16, 2011 and September 29, 2011. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN, NY, TN
___________________________________
PRODUCT
Platelets Leukocytes Reduced. Recall # B-0198-12
CODE
Units: W115111298930G Part 1; W115111298930G Part 2; W115111298931E Part 1
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by fax on September 10, 2011. Firm initiated recall is complete.
REASON
Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0202-12
CODE
Unit: FM99395
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Merced, CA, by telephone on July 2, 2007. Firm initiated recall is complete.
REASON
Blood product, collected under conditions where the sterility of the product may have been compromised, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
___________________________________
PRODUCT
1) 8F Safe Sheath Introducer, Catalog number: V18. The Valved Introducer sheath is utilized to surgically place the catheter during the port implantation procedure. Recall # Z-3064-2011;
2) 8F Smart Port CT, Catalog number: CT80STPD and CT80STPD-NF. The Smart Port CT Implantable Port is a Single Titanium Port System with Attachable 8.0 Fr. Polyurethane Catheters and 8Fr. Introducer Kit. Recall # Z-3065-2011
CODE
1) Lot numbers D1-01664 and D101799;
2) None
RECALLING FIRM/MANUFACTURER
Angiodynamics, Inc., Manchester, GA, by letter dated August 1, 2011. Firm initiated recall is ongoing.
REASON
The product may contain an incorrect size catheter and introducer.
VOLUME OF PRODUCT IN COMMERCE
1095 total units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Straumann coDiagnostiX, version 8.0, used to guide a clinician in the proper implant selection, oral placement and the proper selection of an oral drill. Imaging processing System. Recall # Z-3184-2011
CODE
Software version 8.0 as listed below: listed are the affected articles. Internet Upgrade: 019,0385 @ Upgrade cDX 8 PPP (7+) 019,0386 @ Upgrade cDX 8 Station (7+) 019.0387 @ Upgrade cDx 8 coDoctor (7+) 019.0388 @ Upgrade cDX coDoctor (7+) > PPP 8 0'19.0389 @ Upgrade cDX codoctor (7+) > PPG 8 019.0390 @ Upgrade cDX coDoctor (7+) >Station 8 019.0391 @ Upgrade cDX PPP (7 +):> PPG 8 019.0392 @ Upgrade cDX PPP (7+):> Station 8 019.0393 @ Upgrade coDX PPP > Station 8 Offline Upgrades: 019.0378 Upgrade coDiagnostix 8 PPP (7-) 0'19.0379 Upgrade coDiagnostiX 8 Station (7-) 019.0380 Upgrade coDiagnostiX 8 coDoctor (7-) 019.0381 Upgrade coDoctor (7-) -> PPP 8 019.0382 Upgrade coDoctor (7-) -> PPG8 019.0383 Upgrade PPP (7-) -> PPG 8 019.0384 coDiagnostiX CD coDlagnostiX licenses: 019.0370 coDiagnostiX 8 PPP 019.0371 coDiagnostiX 8 PPG 0'19.0372 coDiagnostiX 8 Station, and 019.0373 coDiagnositX 8 coDoctor.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Straumann Manufacturing Inc., Andover, MA, by letter dated August 4, 2011.
Manufacturer: Institut Straumann AG, Basel, Switzerland. Firm initiated recall is ongoing.
REASON
Software version 8.0 has a software anomaly, in which the length is not adjusted accordingly when it is changed after the surgical sleeve position planning step has been completed.
VOLUME OF PRODUCT IN COMMERCE
272 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
4D Integrated Treatment Console v 8.6 with ARIA RT Chart v8.5, all of 4DITC v 8.3; Designed to assist the operator of a radiation therapy device in providing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan. Model No. H51. Recall # Z-3194-2011
CODE
Code numbers: H510010 H512265 H513062 H513649 H514050 H514275 H514422 H514585 H514750 H514905 H515065 H515154 H515261 H510175 H512273 H513078 H513663 H514051 H514277 H514436 H514586 H514752 H514907 H515067 H515156 H515262 H510273 H512278 H513080 H513674 H514053 H514280 H514437 H514590 H514754 H514908 H515068 H515158 H515263 H510280 H512298 H513089 H513690 H514064 H514283 H514440 H514592 H514756 H514910 H515070 H515161 H515264 H510283 H512341 H513092 H513691 H514076 H514285 H514441 H514600 H514758 H514911 H515071 H515163 H515266 H510435 H512357 H513104 H513693 H514079 H514288 H514449 H514601 H514759 H514912 H515072 H515164 H515267 H510600 H512366 H513112 H513697 H514082 H514289 H514456 H514602 H514763 H514913 H515075 H515167 H515270 H510646 H512396 H513174 H513699 H514083 H514291 H514457 H514603 H514768 H514915 H515076 H515169 H515271 H510648 H512398 H513181 H513704 H514084 H514296 H514460 H514604 H514769 H514916 H515077 H515171 H515273 H510665 H512436 H513184 H513707 H514085 H514297 H514461 H514605 H514770 H514917 H515078 H515173 H515275 H510702 H512437 H513185 H513709 H514086 H514300 H514462 H514607 H514778 H514919 H515079 H515174 H515278 H510783 H512454 H513188 H513714 H514098 H514301 H514466 H514608 H514779 H514920 H515080 H515175 H515284 H510794 H512464 H513208 H513715 H514100 H514303 H514467 H514611 H514781 H514922 H515082 H515176 H515285 H510846 H512475 H513210 H513716 H514112 H514304 H514468 H514612 H514782 H514924 H515083 H515178 H515286 H510983 H512509 H513231 H513717 H514114 H514305 H514469 H514613 H514783 H514929 H515085 H515179 H515289 H511003 H512513 H513241 H513733 H514115 H514306 H514471 H514615 H514787 H514934 H515086 H515180 H515291 H511036 H512522 H513249 H513748 H514122 H514307 H514474 H514618 H514788 H514937 H515087 H515182 H515292 H511114 H512532 H513253 H513759 H514123 H514310 H514478 H514619 H514789 H514940 H515088 H515183 H515294 H511176 H512555 H513256 H513761 H514125 H514311 H514481 H514623 H514792 H514942 H515089 H515184 H515298 H511208 H512560 H513265 H513763 H514144 H514316 H514482 H514624 H514793 H514944 H515090 H515188 H515302 H511213 H512568 H513266 H513770 H514147 H514319 H514485 H514625 H514794 H514949 H515091 H515190 H515303 H511246 H512607 H513281 H513773 H514152 H514320 H514487 H514628 H514795 H514951 H515092 H515191 H515304 H511247 H512613 H513289 H513775 H514153 H514326 H514488 H514631 H514796 H514962 H515094 H515192 H515306 H511261 H512618 H513299 H513780 H514155 H514330 H514489 H514632 H514798 H514963 H515099 H515194 H515310 H511276 H512620 H513307 H513789 H514156 H514332 H514490 H514633 H514801 H514967 H515100 H515196 H515314 H511320 H512637 H513314 H513795 H514161 H514336 H514491 H514636 H514804 H514968 H515101 H515197 H515315 H511393 H512643 H513322 H513829 H514164 H514342 H514494 H514638 H514805 H514970 H515102 H515198 H515317 H511399 H512658 H513339 H513831 H514171 H514343 H514497 H514640 H514811 H514971 H515105 H515200 H515318 H511402 H512676 H513353 H513837 H514179 H514344 H514498 H514641 H514812 H514975 H515106 H515201 H515319 H511474 H512677 H513356 H513838 H514184 H514351 H514501 H514643 H514814 H514976 H515107 H515205 H515320 H511489 H512678 H513372 H513862 H514185 H514352 H514507 H514644 H514815 H514980 H515108 H515207 H515321 H511507 H512679 H513379 H513863 H514186 H514355 H514508 H514647 H514817 H514981 H515110 H515209 H515322 H511518 H512687 H513400 H513866 H514191 H514359 H514516 H514648 H514820 H514982 H515112 H515210 H515325 H511563 H512693 H513407 H513869 H514193 H514362 H514517 H514651 H514821 H514983 H515113 H515211 H515328 H511636 H512694 H513441 H513871 H514198 H514364 H514518 H514652 H514824 H514993 H515115 H515212 H515329 H511663 H512710 H513452 H513876 H514201 H514365 H514522 H514654 H514826 H514995 H515116 H515213 H515330 H511679 H512711 H513456 H513877 H514202 H514367 H514529 H514660 H514827 H515005 H515117 H515214 H515336 H511683 H512712 H513462 H513880 H514204 H514374 H514530 H514663 H514828 H515006 H515118 H515220 H515337 H511701 H512716 H513470 H513888 H514208 H514375 H514541 H514664 H514829 H515007 H515121 H515224 H515340 H511724 H512737 H513471 H513892 H514211 H514376 H514544 H514667 H514830 H515009 H515122 H515225 H515341 H511764 H512812 H513477 H513919 H514213 H514378 H514546 H514668 H514832 H515011 H515123 H515227 H515345 H511768 H512835 H513495 H513929 H514220 H514380 H514547 H514670 H514834 H515012 H515125 H515229 H515346 H511771 H512847 H513496 H513930 H514223 H514386 H514551 H514673 H514843 H515021 H515127 H515231 H515350 H511823 H512856 H513498 H513932 H514224 H514391 H514554 H514675 H514849 H515026 H515129 H515232 H515351 H511846 H512863 H513510 H513939 H514225 H514393 H514556 H514682 H514851 H515033 H515131 H515236 H515353 H511864 H512889 H513520 H513942 H514226 H514394 H514559 H514685 H514852 H515038 H515132 H515238 H515354 H511931 H512938 H513521 H513944 H514228 H514395 H514562 H514688 H514854 H515039 H515134 H515240 H515358 H511961 H512940 H513523 H513957 H514230 H514396 H514564 H514691 H514855 H515043 H515135 H515242 H515360 H511964 H512956 H513527 H513959 H514231 H514398 H514565 H514692 H514856 H515045 H515141 H515244 H515361 H511982 H512959 H513528 H513962 H514232 H514400 H514568 H514702 H514857 H515046 H515142 H515246 H515362 H512003 H512962 H513539 H513968 H514249 H514401 H514570 H514703 H514862 H515048 H515143 H515248 H515365 H512012 H512978 H513546 H513980 H514257 H514407 H514572 H514708 H514863 H515050 H515144 H515249 H515366 H512029 H512980 H513547 H513982 H514258 H514408 H514574 H514711 H514875 H515055 H515145 H515250 H515369 H512097 H512987 H513549 H513995 H514262 H514410 H514575 H514716 H514876 H515056 H515147 H515251 H515370 H512120 H512989 H513561 H514006 H514269 H514411 H514577 H514722 H514880 H515059 H515148 H515253 H515371 H512131 H512990 H513575 H514008 H514270 H514412 H514578 H514723 H514881 H515060 H515150 H515257 H515373 H512163 H512998 H513600 H514009 H514272 H514416 H514579 H514724 H514890 H515061 H515151 H515258 H515376 H512184 H513011 H513626 H514022 H514273 H514417 H514580 H514735 H514898 H515062 H515152 H515259 H515377 H512226 H513045 H513648 H514032 H514274 H514420 H514581 H514736 H514899 H515063 H515153 H515260 H515379 H515380 H515502 H515630 H515753 H515894 H518106 H515381 H515504 H515632 H515755 H515895 H518107 H515382 H515505 H515633 H515756 H515896 H518116 H515384 H515506 H515638 H515757 H515897 H518117 H515385 H515507 H515641 H515758 H515898 H518120 H515387 H515510 H515642 H515761 H515900 H518122 H515392 H515513 H515643 H515765 H515901 H518128 H515394 H515514 H515644 H515767 H515902 H518129 H515397 H515515 H515646 H515771 H515903 H518130 H515398 H515516 H515648 H515774 H515904 H518131 H515400 H515518 H515650 H515776 H515906 H518132 H515401 H515522 H515658 H515777 H515907 H518136 H515405 H515527 H515663 H515778 H515908 H518139 H515406 H515528 H515664 H515782 H515912 H518145 H515408 H515530 H515666 H515784 H515914 H518150 H515409 H515531 H515667 H515785 H515915 H518152 H515410 H515532 H515669 H515789 H515917 H518153 H515412 H515533 H515670 H515796 H515918 H518154 H515414 H515534 H515673 H515797 H515920 H518156 H515415 H515535 H515674 H515798 H515924 H518157 H515417 H515536 H515676 H515800 H515925 H518161 H515418 H515541 H515679 H515801 H515926 H518164 H515419 H515543 H515680 H515802 H515929 H518170 H515420 H515545 H515681 H515805 H515932 H518171 H515421 H515552 H515685 H515809 H515934 H518172 H515422 H515553 H515686 H515810 H515936 H518173 H515427 H515554 H515687 H515811 H515937 H518182 H515430 H515560 H515690 H515812 H515942 H518185 H515431 H515561 H515694 H515813 H515946 H518186 H515432 H515562 H515695 H515818 H515947 H518187 H515433 H515563 H515699 H515819 H515948 H518188 H515435 H515566 H515700 H515820 H515951 H518189 H515436 H515567 H515701 H515825 H515960 H518192 H515439 H515568 H515702 H515827 H515961 H518200 H515442 H515570 H515703 H515828 H515962 H51A001 H515445 H515578 H515705 H515831 H515963 H51A002 H515446 H515579 H515706 H515833 H515964 H51B002 H515447 H515581 H515707 H515837 H515965 H51B003 H515452 H515585 H515711 H515839 H515974 H51B004 H515454 H515587 H515712 H515840 H515975 H51B005 H515455 H515589 H515713 H515841 H515976 H51B006 H515456 H515591 H515714 H515842 H515979 H51B008 H515460 H515595 H515715 H515846 H515980 H51B012 H515461 H515596 H515716 H515847 H515981 H51B014 H515462 H515597 H515718 H515848 H515983 H51B016 H515464 H515598 H515723 H515850 H515984 H51B020 H515465 H515599 H515724 H515856 H515985 H51B028 H515472 H515601 H515728 H515857 H515989 H51B031 H515474 H515604 H515730 H515861 H515991 H51B032 H515475 H515607 H515731 H515874 H515992 H51B035 H515476 H515610 H515734 H515875 H515993 H51B036 H515477 H515613 H515736 H515877 H515997 H51B043 H515478 H515615 H515740 H515878 H515998 H51B045 H515480 H515619 H515741 H515880 H515999 H515484 H515620 H515742 H515882 H517058 H515485 H515621 H515743 H515884 H517059 H515490 H515623 H515746 H515888 H517241 H515491 H515624 H515747 H515889 H517545 H515492 H515625 H515748 H515890 H517567 H515494 H515626 H515749 H515891 H517892 H515500 H515628 H515751 H515892 H518104
RECALLING FIRM/MANUFACTURERO
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letters on on July 21, 2011. Firm initiated recall is ongoing.
REASON
The 4D Integrated Treatment Console may erratically fail to load the planned physical wedge accessory without warning or notification when receiving an approved plan from the oncology information system.
VOLUME OF PRODUCT IN COMMERCE
1,125 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
COULTER DxH Cell Lyse, Part number 628018(1L) and 628019 (5L). The COULTER DxH Cell Lyse is an erythrocyte lytic agent used for quantitative determination of hemoglobin, enumeration of NRBC, and counting and sizing leukocytes on UniCel DxH 800 Coulter Cellular Analysis System. Recall # Z-3263-2011
CODE
Lot Numbers: 0710001, 0710003, 0711002, 0712001, 0710002, 0710004, 0711001, 0711003, and 0712002
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on August 1, 2011.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON
The recall was initiated because Beckman Coulter identified unexpected high particle counts in the lots of DxH Cell Lyse listed. These lots may generate high background counts; could result in a falsely elevated Total Nucleated Count (TNC) of up to 50 cells/L; or may also result in recovery of TNC values that were higher than expected for Level 1 of the Body Fluid Control.
VOLUME OF PRODUCT IN COMMERCE
4,913 units total (2245 In US)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) PERPOS PLS System, Single Use; CATALOG #'s: a) 9045-01 & b) 9045-02. A sterile kit used to stabilize the spine as an aid to fusion through immobilization of the facet joints. Recall # Z-0045-2012;
2) Reusable BONE-LOK PLS System; Catalog #'s: a) 9039-01 and b) 9039-02. A sterile kit used to stabilize the spine as an aid to fusion through immobilization of the facet joints. Sold in Europe. Recall # Z-0046-2012;
3) PERPOS Driver; Catalog # 6112. A cannulated, driver to be used over a K-wire to engage the head of the 4.5mm BONE-LOK PLS Implant (LSW-45-3040) and drive it into the bone. The PERPOS Driver (61 12) is sold as either a component of the Single Use PERPOS PLS System (9045-01, 9045-02), a component of the Reusable BONE-LOK PLS System (9039-01, 9039-02), or as a stand-alone tool. Recall # Z-0047-2012
CODE
1) a) Lot #’s: 010410C, 010508A, 012308A, 021610C, 030309A, 030708A , 031609B, 040209B, 041309B, 050809B, 051309B, 060809B, 061709B, 062009A, 070108A, 070108B, 071009C, 072408A, 102107A, 110909B, 111207A, 120308B, 120807A b)CATALOG NO. 9045-02, Lot #’s: 010410D, 010608A, 011910B, 012408A, 020209B, 020309A, 020510C, 021610D, 030409A, 030808A, 031709A, 032310D, 040110A, 040309A, 041409A, 050709B, 050809C, 051209D, 060209A, 060809C, 061709C, 062009B, 070208A, 070208B, 071009D, 072508A, 090408A, 090508A, 090909E, 092209B, 092909A, 092909B, 102207A, 110909C, 111307A, 112208A, 120408C, 120907A;
2) a) Lot #’s: 092707-01, 102907, 102907-02 thru -03, 120107-01 thru -10, 050208-21 thru -30, 050208-15 thru -16, 050108-01, 041708-01, 050208-11 thru -20, 060208-01 thru -10, 050208-41 thru -47; b) Lot #’s: 050208-11 thru -20, 050108-11;
3) Lot #’s: 050507A, 061509A, 071808A, 112507A, 042709E
RECALLING FIRM/MANUFACTURER
Interventional Spine Inc., Irvine, CA, by letter dated March 15, 2011. Firm initiated recall is ongoing.
REASON
This recall has been initiated due to drivers that may contain a burr in the distal tip preventing full seating of the driver onto the head of the facet screw, resulting in difficulty screwing the facet screw into the bone. Use of this product may result in a delay of the surgical procedure.
VOLUME OF PRODUCT IN COMMERCE
2,692 units
DISTRIBUTION
Nationwide and Italy, Spain, Turkey, and the U.K
___________________________________
PRODUCT
ArthroCare brand MiniMagnum Knotless Fixation Implant Device with Inserter Handle Plus SpeedStitch Magnum Wire Suture Cartridge; Catalog Number: OM-6007; The MiniMagnum Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-Iabral reconstruction, biceps tenodesis and deltoid repair. Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon attachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions. Recall # Z-0049-2012
CODE
Lot Number: 1015833
RECALLING FIRM/MANUFACTURERO
ArthroCare Corp., Sunnyvale, CA, by letter dated May 10, 2011. Firm initiated recall is ongoing.
REASON
ArthroCare initiated the recall of one lot of the MiniMagnum Knotless Implant Fixation Device where the incorrect diver block was packed with the implant.
VOLUME OF PRODUCT IN COMMERCE
32 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Base Camp First Aid Kit, Part Number 4150, UPC 0-91966-04150-3, contains 171 pieces. The kit is labeled in parts: "***BASE CAMP FIRST AID KIT***171 PIECE*** 6 IODINE PREP PADS***". First aid kit. Recall # Z-0119-2012;
2) ARC DISASTER KIT (American Red Cross), Part Number 7201, UPC 0-91966-04708-6, The kit is labeled in parts: "***American Red Cross***Item 7201*** 2 IODINE PREP PADS*** ". First aid kit. Recall # Z-0120-2012;
3) Highlands First Aid Kit, Part Number 4116, UPC 0-91966-04116-9, contains 65 Pieces. The kit is labeled in parts: "***HIGHLANDS FIRST AID KIT***MODEL 4166*** 1 IODINE PREP PADS***”. First aid kit. Recall # Z-0121-2012;
4) Mountain First Aid Kit, Part Number 4118; UPC 0-91966-04118-3, contains 88 Pieces. The kit is labeled in parts: "***MOUNTAIN FIRST AID KIT***MODEL 4118*** 1 IODINE PREP PADS*** First aid kit. Recall # Z-0122-2012;
5) Wilderness First Aid Kit, Part Number 4120; UPC 0-91966-04120-6, contains 110 Pieces. The kit is labeled in parts: "***WILDERNESS FIRST AID KIT***MODEL 4120*** 2 IODINE PREP PADS***First aid kit. Recall # Z-0123-2012
CODE
No codes
RECALLING FIRM/MANUFACTURER
Lifeline First Aid LLC, Wilsonville, OR, by letter dated July 7, 2011. Firm initiated recall is ongoing.
REASON
The first aid kits are recalled because the kits contain Iodine Prep Pad single use wipes which were recalled by Triad.
VOLUME OF PRODUCT IN COMMERCE
26, 150 kits
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS I
___________________________________
PRODUCT
1) 2) Tri State, Calf Advantage 22-20 AM BM Calf Milk Replacer, UPC 883576032916, 1476706-106, 50 lb (22.68 kg) Net Weight. 3) 344650AAA14 ADM Alliance Nutrition ANI 20-20, ALL-MILK, Milk Replacer, 1476956-106, 50 lb (22.67 kg) Net Weight. 4) 34877AAA14 ADM Alliance Nutrition NurseTrate Platinum (no cup), Dairy Herd & Beef Calf Milk Replacer, 1476986-106, 50 lb (22.67 kg) Net Weight. 5) 34911AAA14 ADM Alliance Nutrition, ANI 22-20 ALL MIL Milk Replacer w/CitriStim, Dairy Herd & Beef Calf Milk Replacer, 1476992-106, 50 lb (22.68 kg) Net Weight. 6) 33738AAA14 ADM Alliance Nutrition, NurseTrate PowerMAX 28-18, Dairy Herd & Beef Calf Milk Replacer, 1477102-106, 50 lb (22.67 kg) Net Weight. 7) TPI, 28-20 ALL MILK, Calf Milk Replacer, Dairy Herd & Beef Calf Milk Replacer, UPC 883576031377, 1470760-106, 50 lb (22.68 kg) Net Weight. 8) TPI, 22-22 ALL MILK, Dairy Herd & Beef Calf Milk Replacer Non-Medicated, UPC 883576006443, 1470754-106, 50 lb (22.68 kg) Net Weight. 9) TPI, 22-20 ALL MILK, Dairy Herd & Beef Calf Milk Replacer Non-Medicated, UPC 883576006450, 1470755-106, 50 lb (22.68 kg) Net Weight. 10) Pennfield Dairy feed technologies, STATURE 26-20 with Bio-Mos, MILK REPLACER, Dairy Herd & Beef Calf Milk Replacer, UPC 883576034835, 1473405-106, 50 lb (22.68 kg) Net Weight. 11) Pennfield Dairy feed technologies, ULTRA MILK REPLACER with Bio-Mos, Dairy Herd & Beef Calf Milk Replacer, UPC 883576031254, 1484902-106, 50 lb (22.68 kg) Net Weight 12) Pennfield Dairy feed technologies, MOTHER'S MATCH with Bio-Mos, Dairy Herd & Beef Calf Milk Replacer, UPC 883576007679, 1484950-106, 50 lb (22.68 kg) Net Weight. 13) United Supplier 28/15 BM Dairy Herd & Beef Calf Milk Replacer, UPC 8 8357603184 1, 1472825-106, 50 lb (22.68 kg) Net Weight. 14) Solution 20/20 w/BM, Dairy Herd & Beef Calf Milk Replacer, UPC 8 8357602762 2, 1474814-106, 50 lb (22.68 kg) Net Weight. 15) Solution 2 20/20 with NeoTec4, Dairy Herd & Beef Calf Milk Replacer, UPC 8 8357603454 5, 1474828-106, 50 lb (22.68 kg) Net Weight. 16) Purina Mills, High Energy Nurse Chow #100, Milk replacer to be fed to herd replacement calves, UPC 8 8357600475 3, 0000004, 50 lb (22.68 kg) Net Weight. 17) Purina Mills, High Energy Nurse GRO #100, Milk replacer to be fed to herd replacement calves, UPC 8 8357600505 7, 0033378, 50 lb (22.68 kg) Net Weight. 18) Purina Mills, CORNERSTONE 22:20 BM, Milk replacer to be fed to herd replacement calves, UPC 8 0427302525 4, 0039400, 50 lb (22.68 kg) Net Weight. 19) Purina Mills, CORNERSTONE 28:20 BM, Milk replacer to be fed to herd replacement calves, UPC 8 0427302770 8, 0041975, 50 lb (22.68 kg) Net Weight. 20) Purina Mills, High Energy Nurse CHOW #100 INSURE, Milk replacer to be fed to herd replacement calves, UPC 8 8357600516 3, 0052201, 50 lb (22.68 kg) Net Weight. 21) Purina Mills, High Energy Nurse CHOW #100, Milk replacer to be fed to herd replacement calves, UPC 8 8357600520 0, 0058768, 50 lb (22.68 kg) Net Weight. 22) Purina Mills, CORNERSTONE 22:20, Milk replacer to be fed to herd replacement calves, UPC 8 8357600524 8, 0062916, 50 lb (22.68 kg) Net Weight. 23) Purina Mills, CORNERSTONE 28:20, Dairy Herd & Beef Calf Milk Replacer, UPC 8 8357600528 6, 0062919, 50 lb (22.68 kg) Net Weight. 24) Purina Mills, High Energy Nurse CHOW #100 BM, Milk replacer to be fed to herd replacement calves, UPC 8 8357600531 6, 0064800, 50 lb (22.68 kg) Net Weight. 25) Land O Lakes INSTANT MAXII CARE PLUS, Dairy Herd & Beef Calf Milk Replacer, UPC 8 8357601277 2, 1520003-106, 50 lb (22.68 kg) Net Weight. 26) Land O Lakes INSTANT AMPLIFIER DUAL BM, Dairy Herd & Beef Calf Milk Replacer, UPC 8 8357603109 4, 1486702-106, 50 lb (22.68 kg) Net Weight. 27) Land O Lakes INSTANT MAXII CARE BM, Dairy Herd & Beef Calf Milk Replacer, UPC 8 8357603104 9, 1501120-106, 50 lb (22.68 kg) Net Weight. 28) Land O Lakes INSTANT COW'S MATCH JERSEY BLEND BM, Dairy Herd & Beef Calf Milk Replacer, UPC 8 8357603107 0, 1486402-106, 50 lb (22.68 kg) Net Weight. 29) Land O Lakes INSTANT COW'S MATCH BM, Dairy Herd & Beef Calf Milk Replacer, UPC 8 8357600770 9, 1485202-106, 50 lb (22.68 kg) Net Weight. 30) Land O Lakes INSTANT COW'S MATCH w/Celmanax, Dairy Herd & Beef Calf Milk Replacer, UPC 8 8357603493 4, 1485235-106, 50 lb (22.68 kg) Net Weight. 31) Land O Lakes INSTANT COW'S MATCH, Dairy Herd & Beef Calf Milk Replacer, UPC 8 8357600773 0, 1485240-106, 50 lb (22.68 kg) Net Weight. 32) Land O Lakes INSTANT COW'S MATCH JERSEY BLEND , Dairy Herd & Beef Calf Milk Replacer, UPC 8 8357600776 1, 1485245-106, 50 lb (22.68 kg) Net Weight. 33) Land O Lakes INSTANT COW'S MATCH JERSEY BLEND , Dairy Herd & Beef Calf Milk Replacer, UPC 8 8357600777 8, 1485246-106, 50 lb (22.68 kg) Net Weight. 34) Land O Lakes INSTANT COW'S MATCH JERSEY BLEND BOV BM w/FP, Dairy Herd & Beef Calf Milk Replacer, UPC 8 8357603399 9, 1485263-106, 50 lb (22.68 kg) Net Weight. 35) Land O Lakes INSTANT COW'S MATCH , Dairy Herd & Beef Calf Milk Replacer, UPC 8 8357600784 6, 1485270-106, 50 lb (22.68 kg) Net Weight. 36) Land O Lakes PASTEURIZED MILK BALANCER (for use with pasteurized milk), Dairy Herd & Beef Calf Milk Replacer, UPC 8 8357600757 0, 1482506-106, 50 lb (22.68 kg) Net Weight. 37) Land O Lakes INSTANT IAMPLIFIER MAX, Dairy Herd & Beef Calf Milk Replacer, UPC 8 8357603237 4, 1482900-103, 25 lb (11.34 kg) Net Weight. 38) Land O Lakes INSTANT AMPLIFIER MAX, Dairy Herd & Beef Calf Milk Replacer, UPC 0 3450098246 7, 1482900-106, 50 lb (22.68 kg) Net Weight. 39) Land O Lakes INSTANT AMPLIFIER BLENDER, Dairy Herd & Beef Calf Milk Replacer, UPC 8 8357600760 0, 1482905-106, 50 lb (22.68 kg) Net Weight. 40) Land O Lakes INSTANT AMPLIFIER MAX BM, Dairy Herd & Beef Calf Milk Replacer, UPC 8 8357600761 7, 1482910-106, 50 lb (22.68 kg) Net Weight. 41) Land O Lakes INSTANT AMPLIFIER MAX BM, Dairy Herd & Beef Calf Milk Replacer, UPC 8 8357601288 8, 1482912-106, 50 lb (22.68 kg) Net Weight. 42) Land O Lakes INSTANT AMPLIFIER MAX (no cup), Dairy Herd & Beef Calf Milk Replacer, UPC 8 8357600762 4, 1482930-106, 50 lb (22.68 kg) Net Weight. 43) Land O Lakes INSTANT AMPLIFIER MAX , Dairy Herd & Beef Calf Milk Replacer, UPC 8 8357600763 1, 1482940-106, 50 lb (22.68 kg) Net Weight. 44) Land O Lakes CALF BALANCE 22, Dairy Herd & Beef Calf Milk Replacer, UPC 0 3450098086 9 1459900-106, 50 lb (22.68 kg) Net Weight. 45) Land O Lakes DAIRY CALF CHOICE 22-20, Dairy Herd & Beef Calf Milk Replacer, UPC 6 8357600570 5, 1460201-106, 50 lb (22.68 kg) Net Weight. 46) Land O Lakes INSTANT NURSING FORMULA, Dairy Herd & Beef Calf Milk Replacer, UPC 0 3450098095 1, 1462000-106, 50 lb (22.68 kg) Net Weight. 47) Land O Lakes INSTANT NURSING FORMULA BM, Dairy Herd & Beef Calf Milk Replacer, UPC 8 8357603271 8, 1462005-106, 50 lb (22.68 kg) Net Weight. 48) Land O Lakes AMPLIFIER MAX INSTANTANEO, Sustituto de Leche para bovinos productores de leche, UPC 8 8357603071 4, 1489801-108, Peso Neto 20 kg. 49) NUPLEN MILK INSTANTANEO, Sustituto de Leche para Bovinos, UPC 8 8357603060 8, 1479105-109, Peso Neto 25 kg. 54) VALLEY CALF BALANCER (for use with pasteurized milk) DAIRY HERD & BEEF CALF MILK REPLCER, UPC: 8 8357603220 6, 1504410-106, 50 lb (22.68 kg) Net Weight. 55) BRAUM'S 22-20 CALF MILK REPLACER, DAIRY HERD & BEEF CALF MILK REPLCER, UPC: 8 8357600934 5, 1462100-106, 50 lb (22.68 kg) Net Weight. 56) GILMAN CREAMERY 22-20 BM, DAIRY HERD & BEEF CALF MILK REPLCER, UPC: 8 8357603512 2, 1462140-106, 50 lb (22.68 kg) Net Weight. 57) KDS FARMS HEIFERS 24-20 ALL MILK, DAIRY HERD & BEEF CALF MILK REPLCER, UPC: 8 8357603566 5, 1463312-106, 50 lb (22.68 kg) Net Weight. 58) LANDMRK SERVICES CALF PRO 22-20 w/BM, DAIRY HERD & BEEF CALF MILK REPLCER, UPC: 8 8357603100 1, 1464812-106, 50 lb (22.68 kg) Net Weight. 59) MILK REPLACER 22-22, DAIRY HERD & BEEF CALF MILK REPLCER, UPC: 8 8357601329 8, 1466013-106, 50 lb (22.68 kg) Net Weight. 60) COOPERATIVE SERVICES 22-20 ALL MILK CMR BM, DAIRY HERD & BEEF CALF MILK REPLCER, UPC: 8 8357603174 2, 1470251-106, 50 lb (22.68 kg) Net Weight. 61) FARMERS CHOICE 22-20 BM, DAIRY HERD & BEEF CALF MILK REPLCER, UPC: 8 8357603167 4, 1470559-106, 50 lb (22.68 kg) Net Weight. 62) SHUR-GAIN 26-16 ALL MILK, HIGH PERFORMANCE WITH BIO-MOS INSTANT CALF MILK REPLACER, DAIRY HERD & BEEF CALF MILK REPLCER, UPC: 8 8357603419 4, 1472806-106, 50 lb (22.68 kg) Net Weight. 63) MIDWEST 22-20 ALL MILK CALF MILK REPLACER w/CELMANAX, DAIRY HERD & BEEF CALF MILK REPLCER, UPC: 8 8357603400 2, 1473825-106, 50 lb (22.68 kg) Net Weight. 64) NUTRA BLEND 22/20 AM INSTANT CALF MILK REPLACER, DAIRY , UPC: 8 8357600729 7, 1474108-103, 25 lb (11.34 kg) Net Weight. 65) NATURAL CLAF 20-20 NON-MEDICATED, DAIRY HERD & BEEF CALF MILK REPLCER, UPC: 8 8357600910 9, 1483050-1003, 250 lb (11.34 kg) Net Weight. 66) JD HEISKELL ELITE 28-20, DAIRY HERD & BEEF CALF MILK REPLCER, UPC: 8 835760333379 1, 1486517-106, 50 lb (22.68 kg) Net Weight. 66a) ALL MILK 22-20 NON MEDICATED BM, DAIRY HERD & BEEF CALF MILK REPLACER, UPC: 8 83576 03134 6, 1464310-106, 50 lb (22.68 kg) Net Weight. 66b) NUTRA BLEND 22/20 AM, INSTANT CALF MILK REPLACER, UPC: 8 83576 00909 3, 1474108-106, 50 lb (22.68 kg) Net Weight. Recall # V-402-2011;
2) 50) NUPLEN MILK SELECT, INSTANTANEO, Sustituto de Leche para BECERROS, UPC 8 8357603071 7, 1489502-109, Peso Neto 25 kg. 51) Land O Lakes COW'S MATCH INSTANTANEO, Sustituto de Leche para BECERROS, UPC 8 8357603073 8, 1485295-106, Peso Neto 50 kg. 52) Land O Lakes INSTANT AMPLIFIER MAX, Sustituto de Leche para BECERROS, UPC 8 8357603068 4, 1489125-108, Contenido neto 20, 22.680, 25, 40 y 50 kg. Recall # V-403-2011;
3) 53) Land O Lakes LitterMIlk CON PRT 99, Sustituto de Leche para LECHONES, UPC 8 8357603061 5, 1515415-107, Contenido neto 5, 10, 11.350, 20 y 22.700 kg. Recall # V-404-2011;
4) 69AB30 LASALOCID 69) LAND O LAKES, INSTANT COWS MATCH BOV MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 00778 5, 1485250-106, 50 lb (22.68 kg) Net Weight. 70) NW IA CALF MILK REPLACER, BOV 22-20 BM MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03250 3, 1465018-106, 50 lb (22.68 kg) Net Weight. 71) LAND O LAKES, HERD MAKER, 20-20 BOV BM, MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03219 0, 1466038-106, 50 lb (22.68 kg) Net Weight. 72) LAND O LAKES, INSTANT NURSING FORMULA BOV-BM, MEDICATED, Dairy Herd & Beef Calf Milk Replacer,1470401-106, 50 lb (22.68 kg) Net Weight. 73) LAND O LAKES, INSTANT NURSING FORMULA BOV, MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 0 34500 98099 9, 1470400-106, 50 lb (22.68 kg) Net Weight. 74) LAND O LAKES, INSTANT NURSING FORMULA BOV, MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03341 8, 1470400-103, 25 lb (11.34 kg) Net Weight. 75) LAND O LAKES, INSTANT AMPLIFIER MAX BOV (LBA), MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 00756 3, 1481300-106, 50 lb (22.68 kg) Net Weight. 76) NVA CALF MILK REPLACER 22-20 BOV BM MEDICATED DAIRY HERD & BEEF CALF MILK REPLACER, UPC 8 83576 03200 8, 1474041-106, 50 lb (22.68 kg) Net Weight. 77) LAND O LAKES, INSTANT COWS MATCH JERSEY BLEND BOV BM, MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03218 3, 1485259-106, 50 lb (22.68 kg) Net Weight. 78) LAND OLAKES, INTANT COWS MATCH JERSEY BLEND BOV , MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 00781 5, 1485255-106, 50 lb (22.68 kg) Net Weight 79) LAND O LAKES, INSTANT COWS MATCH BOV BM, MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 00779 2, 1485252-106, 50 lb (22.68 kg) Net Weight 80) LAND O LAKES, INSTANT AMPLIFIER MAX BOV 2XBM, MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03241 1, 1486015-106, 50 lb (22.68 kg) Net Weight 81) LAND O LAKES, INSTANT AMPLIFIER MAX BOV- BM, MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 00789 1, 1486010-106, 50 lb (22.68 kg) Net Weight. 82) LAND O LAKES, INSTANT AMPLIFIER MAX BOV, MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 0 34500 98269 6, 1486000-106, 50 lb (22.68 kg) Net Weight. 83) LAND O LAKES, INSTANT AMPLIFIER MAX BOV, MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03205 3, 1486000-103, 25 lb (11.34 kg) Net Weight. 84) LAND O LAKES, INSTANT AMPLIFIER SELECT PLUS BOV, MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 0 34500 98283 2, 1485900-106, 50 lb (22.68 kg) Net Weight. 85) LAND O LAKES, INSTANT MAXI CARE PLUS BOV BM, MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 01706 7, 1520010-106-106, 50 lb (22.68 kg) Net Weight. 86) LAND O LAKES, INSTANT MAXI CARE BOV, MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 0 34500 98274 0, 1501800-106, 50 lb (22.68 kg) Net Weight. 87) LAND O LAKES, INSTANT AMPLIFIER MAX BOV, MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03157 5, 1487505-106, 50 lb (22.68 kg) Net Weight. 88) LAND O LAKES, INSTANT AMPLIFIER MAX BOV BM, MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03457 6, 1486020-106, 50 lb (22.68 kg) Net Weight. 89) LAND OLAKES, INTANT AMPLIFIER MAX BOV BM (no cup), MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03239 8, 1486019-106, 50 lb (22.68 kg) Net Weight. 90) LAND O LAKES, INSTANT AMPLIFIER MAX BOV BM (no cup), MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03238 1, 1486018-106, 50 lb (22.68 kg) Net Weight. 91) LAND O LAKES, CALF BALANCE 22 BOV MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03150 6, 1451305-103, 25 lb (11.34 kg) Net Weight. 92) Purina Mills. NURSE CHOW #100 BVT BM, MEDICATED, UPC8 04273 02834 7, 0042213, 25 lb (11.34 kg) Net Weight. 93) Purina Mills. Cornerstone 22:20 BOV BM, UPC8 04273 02769 2, 0041974 105z, 50 lb (22.68 kg) Net Weight. 94) Purina Mills. HIGH ENERGY NURSE CHOW #100 BVT , MEDICATED, UPC8 83576 00536 1, 0065299, 50 lb (22.68 kg) Net Weight. 95) Purina Mills. HIGH ENERGY NURSE GROW #100 BVT BM, MEDICATED, UPC8 04273 02831 6, 0042211, 50 lb (22.68 kg) Net Weight. 96) Purina Mills. HIGH ENERGY NURSE CHOW #100 BVT BM, MEDICATED, UPC8 04273 02827 9, 0042207, 50 lb (22.68 kg) Net Weight. 97) Purina Mills. CORNERSTONE 22:20 BVT, MEDICATED, UPC 8 04273 02795 1, 0042113, 50 lb (22.68 kg) Net Weight. 98) Purina Mills CORNERSTONE 28:20 BOV BM MEDICATED, UPC 8 04273 02771 5, 0041987, 50 lb (22.68 kg) Net Weight. 99) Purina Mills CORNERSTONE JERSEY RECIPE 28:25 BOV BM, MEDICATED, UPC 8 83576 03111 7, 0041565, 50 lb (22.68 kg) Net Weight. 100) Purina Mills CORNERSTONE 28:20 BOV MEDICATED, UPC 8 83576 02720 2, 0037234, 50 lb (22.68 kg) Net Weight. 101) Purina Mills CORNERSTONE JERSEY RECIPE 28:25 BOV, MEDICATED, UPC 8 83576 01718 0, 0029569, 50 lb (22.68 kg) Net Weight. 102) Purina Mills HIGH ENERGY NURSE GRO #100 BVT, MEDICATED, UPC 8 83576 00491 3, 0015125, 50 lb (22.68 kg) Net Weight. 103) LANDMARK SERVICES CALF PRO 22-20 BOV MEDICATED, DAIRY HERD & BEEF CALF MILK REPLACER, UPC 8 83576 02928 2, 1460204-106, 50 lb (22.68 kg) Net Weight. 104) CALF CARE ALL MILK BOV MEDICATED, DAIRY HERD & BEEF CALF MILK REPLACER, UPC 8 83576 01451 1, 1472468-106, 50 lb (22.68 kg) Net Weight. 105) OptiMILK Natures Formula (Arctic Blend) ALL-MILK CALF MILK REPLACER, DAIRY HERD & BEEF CALF MILK REPLACER, MEDICATED, UPC 8 83576 00679 5, 1472473-106, 50 lb (22.68 kg) Net Weight. 106) OptiMILK Natures Formula (Summer Blend-BOV) ALL-MILK CALF MILK REPLACER, DAIRY HERD & BEEF CALF MILK REPLACER, MEDICATED, UPC 8 83576 00680 1, 1472474-106, 50 lb (22.68 kg) Net Weight. 107) NUTRA BLEND 22-20 AM BOV MEDICATED DAIRY HERD & BEEF CALF MILK REPLACER , UPC 8 83576 03422 4, 1474113-106, 50 lb (22.68 kg) Net Weight. 108) NUTRA BLEND 22-20 AM BM MEDICATED DAIRY HERD & BEEF CALF MILK REPLACER , UPC 8 83576 03484 2, 1474114-106, 50 lb (22.68 kg) Net Weight. 109) COOP 24-20 BOV BM w/Plasma MEDICATED DAIRY HERD & BEEF CALF MILK REPLACER , UPC 8 83576 03475 0, 1472545-106, 50 lb (22.68 kg) Net Weight. 110) SOUTHERN STATES, CALF MAKER BOV BM MEDICATED DAIRY HERD & BEEF CALF MILK REPLACER , UPC 8 83576 03156 8, 1476650-106, Net Weight Shown On Bag. 111) HEWITT BROTHERS INC, HIGH PROTEIN ALL MILK 25/20 BOV BM INSTANT CALF MILK REPLACER MEDICATED, UPC 8 83576 00678 8, 1472472-106, 50 lb (22.68 kg) Net Weight. 112) HEWITT BROTHERS INC, SUPER RED ALL MILK 20/20 CALF MILK REPLACER MEDICATED, UPC 8 83576 00668 9, 1472412-106, 50 lb (22.68 kg) Net Weight. 113) NS, CONSUMERS PERFORMANCE BOV BM with Sel-Plex , MEDICATE DAIRY HERD & BEEF CALF MILK REPLACER, UPC 8 83576 03549 8, 1468206-106, 50 lb (22.68 kg) Net Weight. 114) FEED COMMODITIES International, Inc., CUSTOM CALF GOLD BOV with Bio-Mos MEDICATED All Milk Formula MEDICATE DAIRY HERD & BEEF CALF MILK REPLACER, UPC 8 83576 03196 4, 1467753-106, 50 lb (22.68 kg) Net Weight. 115) FEED COMMODITIES International, Inc., CUSTOM CALF WHITE PLUS BOV with Bio-Mos, All Milk Formula, MEDICATED All Milk Formula MEDICATE DAIRY HERD & BEEF CALF MILK REPLACER, UPC 8 83576 03197 1, 1463451-106, 50 lb (22.68 kg) Net Weight. 116) Alliance Marketing, NUTRA MILK 25/20 BOV BM Instant Calf Milk Replacer, 1472004-106, 50 lb (22.68 kg) Net Weight. 117) Alliance Marketing, NUTRA MILK 22/20 BOV BM MEDICATED DAIRY HERD & BEEF CALF MILK REPLACER, UPC 8 83576 03347 0 1465009-106, 50 lb (22.68 kg) Net Weight. 118) 34650DKE14, ADM Alliance Nutrition, ANI 20-20 ALL-MILK BOV MEDICATED DAIRY HERD & BEEF CALF MILK REPLACER, 1476971-106, 50 lb (22.67 kg) Net Weight. 119) 33741DKE14, ADM Alliance Nutrition, NurseTrate ALL-MILK BOV MEDICATED DAIRY HERD & BEEF CALF MILK REPLACER, 1476988-106, 50 lb (22.67 kg) Net Weight. 120) 33738BHA14, ADM Alliance Nutrition, NurseTrate PowerMAX 28-18 BOV MEDICATED DAIRY HERD & BEEF CALF MILK REPLACER, 1477101-106, 50 lb (22.67 kg) Net Weight. 121) MICHIGAN MILK PRODUCERES ENHANCED GROWTH FORMULA 25/20 BOV MEDICATED DAIRY HERD & BEEF CALF MILK REPLACER, UPC 8 83576 03193 3, 1473311-106, 50 lb (22.67 kg) Net Weight. 122) IAS, Health Star 22-20 BOV BM MEDICATED DAIRY HERD & BEEF CALF MILK REPLACER, UPC 8 83576 03187 2, 1478005-106, 50 lb (22.67 kg) Net Weight. 123) CAROLINA DAIRY PLUS 28-20 BOV with MOS MEDICATED DAIRY HERD & BEEF CALF MILK REPLACER, UPC 8 83576 03243 5, 1485025-106, 50 lb (22.67 kg) Net Weight. 124) GREEN MEADOW FARMS 22-20 BOV (no cup) MEDICATED DAIRY HERD & BEEF CALF MILK REPLACER, UPC 8 83576 03497 2, 1466151-106, 50 lb (22.67 kg) Net Weight. 125) TOTAL LIVESTOCK SERVICES, TLS 20-20 BOV BM MEDICATED DAIRY HERD & BEEF CALF MILK REPLACER, UPC 8 83576 03025 7, 1466321-106, 50 lb (22.67 kg) Net Weight 126) FivePoint EXCEL 22-20 CALF MILK REPLACER BOV with Bio-Mos MEDICATED DAIRY HERD & BEEF CALF MILK REPLACER, UPC 8 83576 03185 8, 1470322-106, 50 lb Net Weight 127) LAPEER 20-20 BOV BM Calf Milk Replacer MEDICATED DAIRY HERD & BEEF CALF MILK REPLACER, UPC 8 83576 00914 7, 1467240-106, 50 lb Net Weight. 128) GOLDEN SUN FEEDS, ALL MILK 22/20 BOV BM MILK REPLACER MEDICATED, UPC 8 04273 02887 3, 0042526, 107 g, 50 lb Net Weight. 129) BOWMANS 22-20 ALL MILK BM MEDICATED, UPC 8 04273 02763 0, 0041961, 105T, 50 lb Net Weight. 130) Farmers UNION COOPERATIVE SUPREME CALF CHOICE 22-20 BOV BM MEDICATED, UPC 8 83576 03173 5 1464002-106, 50 lb Net Weight. 131) LUEKEN DAIRY 28-20 BVT CALF MILK REPLACER MEDICATED DAIRY HERD & BEEF CALF MILK REPLACER, UPC 8 83576 03514 6, 1471812-106, 50 lb Net Weight. Recall # V-405-2011;
5) 69AB20 DECOQUIANTE 132) LAND O LAKES, INSTANT NURSING FORMULA DC MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 0 34500 98090 6, 1460100-106, 50 lb (22.68 kg) Net Weight. 133) LAND O LAKES, INSTANT AMPLIFIER MAX DC BM MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 04273 02898 9, 1482805-106, 50 lb (22.68 kg) Net Weight. 134) LAND O LAKES, INSTANT AMPLIFIER MAX DC BM (2X) (no cup) MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 02212 2, 1482802-106, 50 lb (22.68 kg) Net Weight. 135) LAND OLAKES, INTANT AMPLIFIER MAX DC BM (2X) MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 00759 4, 1482801-106, 50 lb (22.68 kg) Net Weight. 136) LAND O LAKES, INSTANT AMPLIFIER MAX DC MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 0 34500 98244 3, 1482800-106, 50 lb (22.68 kg) Net Weight. 137) LAND O LAKES, INSTANT AMPLIFIER COWS MATCH DC BM MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03106 3, 1486401-106, 50 lb (22.68 kg) Net Weight. 138) LAND O LAKES, INSTANT COWS MATCH DC MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 00793 8, 1486400-106, 50 lb (22.68 kg) Net Weight. 139) SAME AS 132. 140) Purina Mills CORNERSTONE 28:20 DQ, MEDICATED, UPC 8 83576 00527 9, 0062920, 50 lb (22.68 kg) Net Weight. 141) Purina Mills CORNERSTONE 22:20 DQ, MEDICATED, UPC 8 83576 00525 5, 0062917 10PB, 50 lb (22.68 kg) Net Weight. 142) Purina Mills CORNERSTONE 22:20 DQ BM, MEDICATED, UPC 8 8 04273 02796 8, 0042114 106P, 50 lb (22.68 kg) Net Weight. 143) Purina Mills HIGH ENERGY NURSE CHOW #100 DQ, MEDICATED, UPC 8 83576 00481 4, 0000017 10C3, 50 lb (22.68 kg) Net Weight. 144) SOLUTION 20-20 DCX MEDICATED, , Dairy Herd & Beef Calf Milk Replacer, 8 83576 02656 4, 1474813-106, 50 lb (22.68 kg) Net Weight. 145) ADVANCED CALF TECHNOLOGY, FIRST FOOD CR-DCX sith Bio-Mos, MEDICATED INSTANTIZED CALF MILK REPLACER, UPC 8 83576 03168 1M 1472533-106, 50 lb (22.68 kg) Net Weight. 146) NUTRA BLEND 22-20 AM BOV BM with ClariFly MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03571 9, 1474116-106, 50 lb (22.68 kg) Net Weight. 147) 33741AZW16, ADM Alliance Nutrition, Nurse Trate All-Milk DC, MEDICATED, Dairy Herd & Beef Calf Milk Replacer, 1476975-103, 50 lb (22.68 kg) Net Weight. 148) 33741AZW14, ADM Alliance Nutrition, Nurse Trate All-Milk DC, MEDICATED, Dairy Herd & Beef Calf Milk Replacer, 1476975-106, 50 lb (22.68 kg) Net Weight 149) 34813AZW16, ADM Alliance Nutrition, Nurse Trate Platinum DC, MEDICATED, Dairy Herd & Beef Calf Milk Replacer, 1476979-103, 25 lb (11.34 kg) Net Weight 150) 34813AZW14, ADM Alliance Nutrition, Nurse Trate Platinum DC, MEDICATED, Dairy Herd & Beef Calf Milk Replacer, 1476979-106, 50 lb (22.68 kg) Net Weight 151) KWC 20/20 ALL MILK DC INSTANT CALF MILK REPLACER MEDICATED, 8 83576 02948 0, 1473736-106, 50 lb (22.68 kg) Net Weight. 152) MUNSON LAKES NUTRITION 22/20 ALL MILK DC MEDICATED DAIRY HERD & BEEF CALF MILK REPLACER, , 8 83576 00659 7, 1471640-106, 50 lb (22.68 kg) Net Weight. 153) PREMIUM ALL MILK 22-20 DC CALF MILK REPLACER MEDICATED, 8 83576 00683 2, 1472603-106, 50 lb (22.68 kg) Net Weight. 153a) MFA AAA 20-20 DC MEDICATED, DAIRY HERD & BEEF CALF MILK REPLACER, UPC: 8 83576 00559 0, 1460042-106, 50 lb (22.68 kg) Net Weight. Recall # V-406-2011;
6) 69BB44 NEO & OXY 154) LAND O LAKES, INSTANT NURSING FORMULA NT(16:16) MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03139 1, 1474510-106, 50 lb (22.68 kg) Net Weight. 155) LAND O LAKES, HERD MARKER 20-20 NT 16:16, MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03209 1, 1466034-106, 50 lb (22.68 kg) Net Weight. 156) Purina Mills. HIGH ENERGY NURSE CHOW #100 NT (1300:1300) MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03550 4, 0047291, 50 lb (22.68 kg) Net Weight. 157) Purina Mills NURSE CHOW #300 NEO-OTC 16:16 MEDICATED, UPC8 04273 02804 0, 0042142 106R, Distributed by: PURINA MILLS, LLC, PO BOX 66812, St Louis, Missouri 63166-6812, 50 lb (22.68 kg) Net Weight. 158) Purina Mills, NURSE CHOW #200 NEO-OTC 16:16 MEDICATED, UPC8 04273 02802 6, 0042141 106Q, Distributed by: PURINA MILLS, LLC, PO BOX 66812, St Louis, Missouri 63166-6812, 50 lb (22.68 kg) Net Weight. 159) Purina Mills. HIGH ENERGY NURSE CHOW #100 NT 16:16 MEDICATED, UPC8 04273 02755 5, 0041884 105Q, Distributed by: PURINA MILLS, LLC, PO BOX 66812, St Louis, Missouri 63166-6812, 50 lb (22.68 kg) Net Weight. 160) Purina Mills. NURSE CHOW #100 NEO-OTC 16:16 MEDICATED, UPC8 04273 02837 8, 0042252 106S, 25 lb (11.34 kg) Net Weight. 161) Purina Mills. NURSE CHOW #200 NEO-OTC 16:16 MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC8 02839 2, 0042251 106Q, 25 lb (11.34 kg) Net Weight. 162) LANDMARK SERVICES CALF PRO 22-20 NT (1300:1300) BM MEDICATED DAIRY HERD & BEEF CALF MILK REPLACER, 8 83576 03526 9, 1464815-106, 50 lb (22.68 kg) Net Weight. 163) LANDMARK SERVICES CALF PRO 20-20 NT 16 w/BM MEDICATED DAIRY HERD & BEEF CALF MILK REPLACER, 8 83576 03102 5, 1464810-106, 50 lb (22.68 kg) Net Weight. Recall # V-407-2011;
7) LASALOCID & DIFLUBENZURON 164) LAND O LAKES, INSTANT MAXI CARE PLUS BOV DBZ (ClariFly) MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03314 2, 1520015-106, 50 lb (22.68 kg) Net Weight. 165) LAND O LAKES, COS MTCH BOV BM DBZ (ClariFly) MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03510 8, 1485267-106, 50 lb (22.68 kg) Net Weight. 166) CALF CHOICE 21-20 BOV-BM DBZ (ClariFly) MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03501 6, 1470020-106, 50 lb (22.68 kg) Net Weight. 167) LAND O LAKES, INSTANT NURSING FORMULA BOV DBZ (ClariFly) MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03362 3, 1470403-106, 50 lb (22.68 kg) Net Weight. 168) LAND O LAKES, PASTEURIZED MILK BALANCER (at ½#) (for use with pasteurized milk) BOV with ClariFly MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03320 3, 1482508-106, 50 lb (22.68 kg) Net Weight. 169) LAND O LAKES COWS MATCH JERSEY BLEND BOV DBZ (ClariFly) MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03567 2, 1485275-106, 50 lb (22.68 kg) Net Weight. 170) LAND O LAKES, COWS MATCH BOV DBZ (ClariFly) MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03318 2, 1485254-106, 50 lb (22.68 kg) Net Weight. 171) LAND O LAKES, COWS MATCH BOV DBZ (ClariFly) MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03317 3, 1485253-106, 50 lb (22.68 kg) Net Weight. 172) LAND O LAKES, AMPLIFIER MAX BOV BM DBZ (ClariFly) MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03316 6, 1486011-106, 50 lb (22.68 kg) Net Weight. 173) LAND O LAKES, AMPLIFIER MAX BOV DBZ (ClariFly) MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03511 5, 1486005-106, 50 lb (22.68 kg) Net Weight. 174) LAND O LAKES, AMPLIFIER MAX BOV DBZ (ClariFly) MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03321 0, 1486001-106, 50 lb (22.68 kg) Net Weight. 175) Purina Mills CORNERSTONE 22:20 BVT BM DBZ (ClariFly) MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 04273 02909 2, 0043182 107Y, 50 lb (22.68 kg) Net Weight. 176) 176) Purina HIGH ENERGY NURSE CHOW #100 BVT BM DBZ (ClariFly) MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 04273 03093 7, 0046705 108V, 50 lb (22.68 kg) Net Weight. 177) Purina Mills HIGH ENERGY NURSE CHOW #100 DQ DBZ (ClariFly) MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 04273 03094 4, 0046706 108W, 50 lb (22.68 kg) Net Weight. 178) MFA 22-20 BOV with ClariFly BM MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03487 3, 1485614-103, 25 lb (11.34 kg) Net Weight. 179) MFA 22-20 BOV with ClariFly BM MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03488 0, 1485614-106, 50 lb (22.68 kg) Net Weight. 180) MFA AAA20-20 BOV with ClariFly BM MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03326 5, 1460052-106, 50 lb (22.68 kg) Net Weight. 181) TFC CALF PRO 20-20 BOV WITH ClariFly MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03325 8, 1472542-103, 25 lb (11.34 kg) Net Weight. 182) TFC CALF PRO 20-20 BOV WITH ClariFly MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03323 4, 1472542-106, 50 lb (22.68 kg) Net Weight. 183) SOUTHERN STATES CALF MAKER BOV BM with ClariFly MEDICATED, Dairy Herd & Beef Calf Milk Replacer, 1476651-103, Net Weight Shown On Bag, 51107102, 1476651-103 184) MILK REPLACER 22-22 BOV with ClariFly MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03575 7, 1466014-106, 50 lb (22.68 kg) Net Weight. 185) NS CONSUMERS 28-20 ALL MILK BOV BM & ClariFly with Sel-Plex MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03520 7 , 1468205-106, 50 lb (22.68 kg) Net Weight 186) NS CONSUMERS PERFORMANCE BOV BM & ClariFly with Sel-Plex MEDICATED, Dairy Herd & Beef Calf Milk Replacer, UPC 8 83576 03440 8 , 1468201-106, 50 lb (22.68 kg) Net Weight. Recall # V-408-2011
CODE
1) Item # Lot # 2) 1476706-106, 0L23 1A18 0K23 3) 1476956-106, 1B01 4) 1476986-106, 0K29 5) 1476992-106, 0K24 0L16 1B02 6) 1477102-106, 0L06 0L22 1A07 1B08 7) 1470760-106, 1A03 1A31 8) 1470754-106, 1A19 9) 1470755-106, 0K19 0L27 1A04 1A19 1A25 1B02 10) 1473405-106, 1A24 11) 1484902-106, 0K19 0L20 1A10 1A24 1B10 12) 1484950-106, 0K19 0L22 1A06 1A24 1B10 13) 1472825-106, 0L15 14) 1474814-106, .0L06 15) 1474828-106, 1B07 . 16) 0000004, .0K24 0L01 1A04 17) 0033378, .0L21 18) 0039400, .0L02 0L08 0L23 0L30 1A06 1A18 1A20 1A27 1B10 19) 0041975, .OK30 0L10 0L15 0L22 1A05/1A06 1A27 1B03 1B10 20) 0052201, 1A06 21) 0058768, .0K24 0L01 0L14 0L21 1A13 1A20 1A25 1B07 22) 0062916, 0L08 0L15 0L20 1A18 1B02 23) 0062919, 0K30 0L10 24) 0064800, 0L16 0L21 1A11 25) 1520003-106, 1A19 26) 1486702-106, .0L06 27) 1501120-106, 0L20 28) 1486402-106, .0L0 0L14 0L23 1A12 29) 1485202-106, .0K22 0K23 0L01 0L06 0L10 0L15 0L22 0L28 1A06 1A11 1A13 1A18 1A27 1B01 1B08 30) 1485235-106, .0K22 31) 1485240-106, 0K30 0L06 0L10 0L22 1A03 1A11 1A18 1A24 1B08 1B11 32) 1485245-106, 0K19 0L29 33) 1485246-106, 0L23 . 34) 1485263-106, 1A25 35) 1485270-106, 0K23 0L22 0L28 1A27 1B11 36) 1482506-106, 0K24 0L16 0L28 1A26 37) 1482900-103, 0L20 1B09 38) 1482900-106, 0K24 0K30 0L20 0L23 0L30 1A06 1A12 1A20 1A24 1B04 1B08 1B09/1B10 39) 1482905-106, 1A04 40) 1482910-106, 0K24 0L09 0L15 0L20 0L23 0L28 1A06 1A10 1A12 1A18 1A27 1B01 1B07 41) 1482912-106, 0K24 0L28 0L30 42) 1482930-106, 0K19 0L30 43) 1482940-106, 0L02 0L20 1A18 1A27 1B01 44) 1459900-106, 0L22 45) 1460201-106, 0L02 0L08 46) 1462000-106, 0L01 47) 1462005-106, 0L14 0L28 48) 1489801-108, 1A05 49) 1479105-109, .0K29 0L08 0L14 0L16 1B04 54) 1504410-106, 1A31 55) 1462100-106, 1B08 56) 1462140-106, 0L02 57) 1463312-106, 1A26 58) 1464812-106, 0L02 0L08 0L28 1A13 1A19 1B02 59) 1466013-106, 1B01 60) 1470251-106, 0L02 1A06 61) 1470559-106, 0K19 0L02 0L08 1A10 1A27 62) 1472806-106, 0L27 1A21 63) 1473825-106,.0L20 0L23 1A18 1B02 64) 1474108-103,0K23 0L28 1B02 65) 1483050-1003, 1A17 66) 1486517-106, 0L28 66a) 1464310-106, 1A04 66b) 1474108-106, 0K24 0L02 1A18 1A27 1B02;
2) Item # Lot # 50) 1489502-109, 0L02 51) 1485295-106, 1A05 52) 1489125-108, 0K22;
3) Item # Lot # 53) 1515415-107, 0K23;
4) Item # Lot # 69) 1485250-106, 0K23 OK30 0L01 0L10 0L15 0L22 0L28 1A03 1A06 1A13 1A18 1B01 1B08 70) 1465018-106, 0K24 1A13 1A27 71) 1466038-106, 0L27 72) 1470401-106, 0K19 0K24 0L21 1A04 1A28 1B08 73) 1470400-106, 0L14 0L16 1A04 1A19 74) 1470400-103, 1A19 1B04 75) 1481300-106, 0L20 76) 1474041-106, 0K24 0L08 0L16 0L27 77) 1485259-106, 0K19 0L06 0L14 1A12 1A18 1A28 78) 1485255-106, 0L06 0L14 1A12 1A25 1B07 79) 1485252-106, 0K22 0K30 0L15 0L22 0L28 1A03 1A05 1A13 1A27 1B01 1B03 1B11 80) 1486015-106, 0L09 1A18 81) 1486010-106, 0K19 0K24 0K30 0L02 0L09 0L15 0L20 0L23 0L28 0L30 1A05 1A06 1A12 1A18 1A20 1A24 1A26 1B02 1B04 1B10 82) 1486000-106, 0K19 0K30 0L09 0L15 0L23 0L28 0L30 1A05 1A12 1A24 1A26 1B02 1B08 83) 1486000-103, 0K19 0L02 1A24 1A26 84) 1485900-106, 1A20 85) 1520010-106, 0K19 86) 1501800-106, 1B02 87) 1487505-106, 0K19 0K30 0L02 0L15 0L20 0L30 1A12 1A18 1A20 1A24 1A26 1B02 88) 1486020-106, 0L09 0L15 1B04 89) 1486019-106, 1A12 90) 1486018-106, 0K24 0L09 1A18 91) 1451305-103, 1A21 92) 0042213, 0K29 93)0041974, 0K19 0K24 0K30 0L09 0L15 0L21 0L23 0L30 1A06 1A11 1A12 1A27 1B02 94)0065299, 0L01 1A25 95) 0042211, 0K19 96)0042207, 0K22 0L03 0L09 0L14 0L17 0L21 0L28 1A07 1A28 1B03 1B09 97) 0042113, 0K19 0K24 0L02 0L09 0L15 0L21 1A06 1A18 1A271B02 98)0041987, 0L02 1A04 1A13 1A28 1B01 1B04 1B09 99)0041565, 0L07 0L27 0L29 100) 0037234, 0K24 0L02 0L22 1B01 1B11 101)0029569, 0K29 102)0015125, 0K22 1A05 103)1460204-106, 0L08 1A14 104)1472468-106, 0L21 105)1472473-106, 0L07 0L21 1A25 106)1472474-106, 0L01 107)1474113-106, 0K24 0L23 108)1474114-106, 1A18 1A27 109)1472545-106, 1A25 110)1476650-106, 0L16 0L20 111) 1472472-106, 0L13 0L31 1B03 112)1472412-106, 0L21 113) 1468206-106, 1B07 114)1467753-106, 0L02 0L16 0L22 0L28 1A05 1A19 1A28 115) 1463451-106, 0L01 0L14 0L28 1A07 1A20 1A28 116)1472004-106, 0L13 117)1465009-106, 0L21 1A11 1A24 1B02 118)1476971-106, 1A19 119) 1476988-106, 1A20 120)1477101-106, 0L15 0L22 1A11 1A18 1A24 1B08 1B11 121)1473311-106, 0L10 0L27 1B03 122)1478005-106, 0K19 0L14 123)1485025-106, 0L28 124)1466151-106, 0L16 1A27 125)1466321-106, 1A26 126)1470322-106, 0L27 127) 1467240-106, 0L14 1A28 128) 0042526, 107 g, 0L16 0L21 1B11 129) 0041961, 105T, 0L08 130) 1464002-106, 0L21 131) 1471812-106, 0L10;
5) Item # Lot # 132) 1460100-106, 0L16 1A04 1A28 133) 1482805-106, 0L09 0L15 0L20 1B08 134) 1482802-106, 0L30 135) 1482801-106, 0K30 0L08 0L15 1A10 1B08 1B10 136) 1482800-106, 0K24 0K30 0L08 0L15 0L20 0L28 1A10 1A27 1B02 1B08 137) 1486401-106, 0L06 1B10 138) 1486400-106, 0K30 0L01 0L28 1A03 1A18 1B01 1B10 139) SAME AS 132 140) 0062920, 0K19 0L15 0L28 1A11 1A18 141) 0062917 10PB, 0L14 0L20 0L23 1A11 1A27 1B04 142) 0042114 106P, 1A27 143) 0000017 10C3, 0L02 0L08 0L16 0L21 1A04 1A11 144) 1474813-106, 0L06 145) 1472533-106, 1B07 146) 1474116-106, 1B02 147) 1476975-103, 0L17 148) 1476975-106, 1A06 1A20 149) 1476979-103, 1A20 150) 1476979-106, 1A20 151) 1473736-106, 1B01 152) 1471640-106, 0L16 1A13 1A28 153) 1472603-106, 0K19 153a) 1460042-106, 1A17;
6) Item # Lot # 154) 1474510-106, 0L14 155) 1466034-106 0L14 156) 0047291 1A13 157) 0042142 106R, 0L17 158) 0042141 106Q, 0L29 159) 0041884 105Q, 0K24 0L13 0L16 0L27 1A04 160) 0042252 106S, 1A28 161) 0042251 106Q, 0K29 162) 1464815-106, 1A06 1A27 163) 1464810-106, 1A17;
7) Item # Lot # 164) 1520015-106 ,1A25 1A27 165) 1485267-106 , 1B03 1B11 166) 1470020-106 , 1A25 167) 1470403-106, 0L28 1A19 1A25 168) 1482508-106 , 0L16 169) 1485275-106 ,1A25 170) 1485254-106, 1A18 1A24 171) 1485253-106, 1A24 1A27 172) 1486011-106, 1A24 1A26 173) 1486005-106, 1B04 174) 1486001-106 , 0L09 1A12 1A24 1A26 175) 0043182 107Y, 1A27 176) 0046705 108V, 1B11 177) 0046706 108W, 1A28 178) 1485614-103, 0L02 0L28 1A18 1A20 1A26 179) 1485614-106, 0L02 0L20 1A12 1 1A18 1A20 180) 1460052-106, 0L01 181) 1472542-103, 0K22 0L13 183) 1476651-103, 1B07 182) 1472542-106, 1A17 184) 1466014-106, 1B01 185) 1468205-106, 0L22 1A13 1B03 186) 1468201-106, 1A18 1A24 1B04
RECALLING FIRM/MANUFACTURER
Recalling Firm: Land O Lakes Purina LLC, Shoreview, MN, by telephone, e-mail and letter dated May 5, 2011.
Manufacturer: Land O Lakes Purina Feed LLC, Black River Falls, WI. Firm initiated recall is ongoing.
REASON
Recall is due to the potential for salmonella contamination.
VOLUME OF PRODUCT IN COMMERCE
4575.7695 tons
DISTRIBUTION
AL, AZ, CA, CO, GA, ID, I L IN, IA, KS, KY, ME, MI, MN, MS, MO, NE, NM, NY, NC, OH, OK, OR, PA, SD, TN, TX, VT, VA WA,WI, Mexico
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II
___________________________________
PRODUCT
Lone Star Commercial Calf Creep Pellets Medicated 1665. Recall # V-409-2011
CODE
B164. The B is a shift and production line designation. 164 is the Julian calendar date that the product was manufactured (June 13, 2011). The code will be on the bottom of the bag next near the area where the bag is sewn.
RECALLING FIRM/MANUFACTURER
Texas Farm Products Co - Feed Mill, Nacogdoches, TX, by telephone on July 11, 2011. Firm initiated recall is ongoing.
REASON
The calf feed contains prohibited materials.
VOLUME OF PRODUCT IN COMMERCE
10 tons shipped as bulk
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) ANTISEDAN (atipamezole hydrochloride) Sterile Injectable Solution, 5.0 mg/mL, Net Contents 10 mL, NADA 141-033, Unit Package: Single Vials. Recall # V-004-2012;
2) DEXDOMITOR (dexmedetomidine hydrochloride) Sterile Injectable Solution - 0.5 mg/mL, Net Contents: 10 mL, NADA 141-267, Unit Package: Single Vials. Recall # V-005-2012
CODE
1) Lot 1399276 (exp. 03/2014);
2) Lot 1391999 (exp. 01/2014)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., New York, NY, by letters dated September 9, 2011 and September 13, 2011.
Manufacturers: Orion Pharmaceutica, Espoo, Finland;
SGD (Saint Gobain Desjonqueres), Mers Les Bains, France.
Firm initiated recall is ongoing.
REASON
Some of the vials may contain foreign particles.
VOLUME OF PRODUCT IN COMMERCE
1) 1,772 bottles; 2) 14,479 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
28% Catfish Feed. Recall # V-006-2012
CODE
None, bulk product
RECALLING FIRM/MANUFACTURER
Recalling Firm: Melick Aquafeed, Catawissa, PA, by letter on October 5, 2011.
Manufacturer: Melick Aquafeed LLC, Greenville, MS. FDA 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
100 tons
DISTRIBUTION
AR, TX
END OF ENFORCEMENT REPORT FOR NOVEMBER 16, 2011
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