Vaccines, Blood & Biologics – 2012 Biologics Recalls

FDA 2012 Biologics Recalls

Date  Notification Brand Name Product Description Reason/Problem Company
8/2/2012 Recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] 25mg/vial Lot # C0072 Genzyme is initiating a voluntary recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] 25mg/vial. This recall was initiated when one Thymoglobulin lot (C0072) failed a periodic stability test for the molecular size distribution test. Genzyme Corporation
6/21/2012 M-M-R® II (Measles, Mumps, and Rubella Virus Vaccine Live) Lot # 0851AA Merck is voluntarily recalling M-M-R® II due to the inadvertent shipment of doses from the lot to US customers. These doses were distributed between May 17, 2012 and May 25, 2012. Merck & Co., Inc.
3/6/2012 GAMMAGARD LIQUID
Immune Globulin Intravenous (Human), 10% Solution
Product Code 1502797 This recall is being conducted as a precautionary measure due to a labeling error noted on the product vial label and unit carton. The labels on the unit carton and product vials indicate an incorrect manufacturing date and expiry date. Baxter Healthcare Corporatioin, Westlake Village, CA
3/2/2012 Plasma Bottle with Saline Adapter Lot 1201553B Haemonetics recently discovered a label discrepancy on the outer carton of Haemonetics’ Plasma Bottles with Saline Adapter lot 1201553B. An undetermined quantity of product from lot number 1201553B contains an incorrect expiration date on the outer carton label only.
Haemonetics Corporation
Braintree, MA
2/29/2012 Blood-Pack Unit with Flex-Excel Red Cell Filter
Product Code 4R1583
Lot Number FM10J08050
Fenwal identified a labeling  issue with one batch of Product code 4R1583 in which the label for the whole blood collection container incorrectly identifies the contents as leukoreduced red cells.
Fenwal, Inc.
Lake Zurich, IL
2/29/2012 Blood-Pack Unit with Flex-Excel Red Cell Filter
Product Code 4R1582
Lot Numbers:
FM11E17034,
FM11G11017,
FM11G18012
Fenwal identified a labeling  issues with three batches of Product code 4R1582 in which the label for the leukoreduced red cell storage container incorrectly identified the contents as non-leukoreduced red cells.
Fenwal, Inc.
Lake Zurich, IL
2/29/2012 Blood-Pack Unit Whole Blood Filter, Fenwal Express System, Product Code 4R3307E

Lot Number: FM10F02019
Fenwal identified a labeling issue with the 4R3307E Blood-Pack unit in which the label for the satellite bag incorrectly identifies the product as Whole Blood.
Fenwal, Inc.
Lake Zurich, IL
2/29/2012 Blood-Pack Unit
Product Code 4R3459
Lot Number FM11J03027
Fenwal identified an assembly issue with the 4R3459 Blood-Pack Unit in which the satellite bag used for the storage of platelets was PL146 instead of the expected PL2209 plastic bag.
Fenwal, Inc.
Lake Zurich, IL
2/10/2012 Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine 0.5mL pre-filled syringes Pfizer Inc voluntarily initiated this recall when it was determined the lot was formulated and filled with expired serotype 3 conjugate material.
Pfizer

New York, New York

1/25/2012 CaridianBCT Trima Accel System Disposable Tubing Sets CaridianBCT has become aware of a defect that occurred during the manufacturing of Trima Accel tubing sets
CaridianBCT, Inc.
Lakewood, CO
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