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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2012 Biologics Recalls

Date  NotificationBrand NameProduct DescriptionReason/Problem Company
12/6/2012Whole Blood Collection Sets Y ConnectorThe purpose of this letter is to inform customers that there is the potential for a leak to occur, at a very low frequency, in the flexible Y connector of the donor line in some Whole Blood Collection Sets.
Haemonetics
Braintree, MA
11/5/2012MTS084024Ortho-Clinical Diagnostics, Inc. (OCD) has received complaints of an incomplete foil seal for specific lots of ID-Micro Typing System™ Gel Cards.  They have isolated the issue to the lots listed above. 
Micro Typing Systems
Pompano Beach, FL
11/5/2012

MTS080515
MTS080017


Ortho-Clinical Diagnostics, Inc. (OCD) has received complaints of an incomplete foil seal for specific lots of ID-Micro Typing System™ Gel Cards. They have isolated the issue to the lots listed above.  
Micro Typing Systems
Pompano Beach, FL
10/18/2012
 
Bio-Rad Multispot HIV-1/HIV-2 Rapid Test
Catalog Number 25228, Lot number 114284
Bio-Rad Laboratories has received reports of decreased reactivity accompanied by a faint
speckling appearance on cartridge membranes when using some vials of Conjugate in the
Multispot HIV-1/HIV-2 Rapid Test, kit lot number 114284. 
Bio-Rad
Redmond, Washington
9/26/2012Evicel and EvithromProduct codes and Lot Numbers for Fibrin Sealant (Human) Evicel  and
Thrombin Topical (Human) Evithrom
Ethicon, Inc. is notifying customers of a manufacturing process deviation that may have potentially led to the production of vials of Thrombin with decreased potency. OMRIX biopharmaceuticals, Ltd. Israel
9/24/2012
Prefilled syringes (NDCa 49281-790-51)
20-dose vials (NDC 49281-790-20)
 
As a precautionary measure, Sanofi Pasteur is voluntarily recalling some lots of Typhim Vi vaccine (prefilled syringes and 20-dose vials). The vaccine met all release requirements at the time of distribution. Sanofi Pasteur is taking this action because these lots are at risk for lower antigen content.
Sanofi Pasteur SA
Marcy L’Etoile, France
8/2/2012Lot # C0072Genzyme 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 # 0851AAMerck 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 1502797This 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
3/2/2012Plasma 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
2/29/2012Blood-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
2/29/2012Blood-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
2/29/2012Product 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
2/29/2012Blood-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 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
1/25/2012Trima 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