Vaccines, Blood & Biologics

2011 Biologics Recalls

Date
Notification
Brand NameProduct DescriptionReason/ProblemCompany
11/8/2011Fluzone, Influenza Virus Vaccine, Single-Dose Vials Fluzone, Influenza Virus Vaccine, Single-Dose Vials NDC 49281-011-10Sanofi Pasteur is notifying customers of an error in the Prescribing Information (PI) that was included in packages of 10 single-dose vials of Fluzone vaccine (National Drug Code [NDC] 49281-011-10).Sanofi Pasteur, Inc.
Swiftwater, Pennsylvania
10/27/2011RECOMBINATE
[Antihemophilic Factor (Recombinant)]
RECOMBINATE
[Antihemophilic Factor (Recombinant)]

Product Code: 1502736 NDC#: 0944-2842-10

Product Lot Number Labeled Kit, Expiration Date

TRA11802AC, 01/23/14

Product Code: 1503132 NDC#: 0944-2844-10
Product Lot Number Labeled Kit, Expiration Date
TRA11810AC, 03/22/14
TRA11803AC, 01/25/14
TRA11803AD, 01/25/14
TRA11810AA, 03/22/14

Product Code: 1503133 NDC#: 0944-2845-10
Product Lot Number Labeled Kit, Expiration Date
TRA11805AA, 02/01/14
TRA11805AB, 02/01/14
TRA11805AC, 02/01/14
TRA11819AA, 06/20/14

Product Code: 1502737 NDC#: 0944-2843-10

Product Lot Number Labeled Kit, Expiration Date
TRA11808AC, 02/23/14
TRA11816AA, 05/18/14
TRB11820AA, 07/14/14
TRA11806AC, 02/07/14

Baxter Healthcare Corporation is notifying customers of a labeling error affecting the expiration date of the Sterile Water for Injection that is packaged as a diluent with RECOMBINATE [Antihemophilic Factor (Recombinant)]. The Sterile Water for Injection label indicates that the shelf life is longer than what is currently approved, and is in conflict with the approved license expiry period. Baxter asks customers to continue using the RECOMBINATE product as labeled on the kit. There is no impact to the safety or efficacy of the product should the Sterile Water for Injection diluents be used at any time through the duration of the kits labeled shelf life (not the shelf life of the Sterile Water for Injection), as it meets all required specifications as labeled.Baxter
Westlake Village, California
10/26/2011GAMMAGARD LIQUID, [Immune Globulin Intravenous (Human)]GAMMAGARD LIQUID, [Immune Globulin Intravenous (Human)]

10%, 1g size, product code 1500190, NDC# 0944-2700-02

Lot Number, Expiration Date

LE12L057AD, 2/20/2014;
LE12L057AE, 2/20/2014;
LE12L071AB, 3/02/2014;
LE12L126AB, 4/8/2014;
LE12L133AC, 4/11/2014;
LE12L199AB, 6/4/2014;

This recall is being conducted as a precautionary measure after the supplier of the glass vials that contain GAMMAGARD LIQUID notified Baxter of the possibility that there may be metallic particles partially embedded in the glass on the interior surface of the vial. Baxter requests customers to immediately stop the usage/distribution of the lots noted above, and to quarantine any units you may still have in your inventory.Baxter
Westlake Village, California
10/4/2011Blood Component Infusion SetProduct Code 4C2223, Blood Component Infusion Set
80 Micron Blood Component Filter Female Luer
Fenwal identified a labeling issue with the 4C2223 Blood Component Infusion Set in which the package label incorrectly states 80 Micron filter when the actual filter size is a standard blood filter of 170-260 micron in size.Fenwal, Inc.
Lake Zurich, Illinois
6/1/2011LeukoSure
Enumeration Kit
Product Name: LeukoSure Enumeration Kit
Part Number: 175621
Lot Number/Expiration date: 5621012K, 02/15/2011; 5621013K, 05/17/2011; 5621014K, 07/26/2011
The Beckman Coulter LeukoSure Enumeration Kits have an incorrect activity on their label due to the activity value for the raw material Ribonuclease A type III-A, utilized as a component of the LeukoSure Stain Reagent.Beckman Coulter, Inc.
Miami, Florida
5/9/2011ARALAST NP [Alpha1-Proteinase Inhibitor (Human)] packaged with BAXJECT II Hi-FlowARALAST NP 0.5G 25ML: Product Code 1502959, NDC# 0944-2812-01
ARALAST NP 1.0G 50ML: Product Code 1502960, NDC# 0944-2822-02
Baxter is requesting that customers discontinue use of the BAXJECT II Hi-Flow device packaged with ARALAST NP [Alpha1-Proteinase Inhibitor (Human)], and discard any unused devices.Baxter AG
Vienna, Austria
4/26/2011Flow-Set FluorospheresesFlow-Set Fluorosphereses: Part Code: 6607007, Lot number: 7524013F, Expiration date: 05/09/2012Customers are asked to follow the instruction on the Flow Set insert in editing stemOne and stemCXP protocols on their XL or FC500 Software with the correct target value.Beckman Coulter, Inc.
Miami, Florida
3/23/2011Bone Marrow Collection Bag (BMSC), C4Y and P1Y Procedure Sets (used on the AS104 Blood Cell Separation Device)Product Name: BMSC
Product Code: 9007341
Batch Numbers: YKT162 and XMT127

Product Name: C4Y (PBSC-LYM-MNC)
Product Code: 9007301
Batch Numbers: ZHT262, ZGT153, ZDT021
ZAT251,YLT112, YKT131

Product Name: P1Y (GRANULO-MNC-BMSC)
Product Code: 9007231
Batch Numbers: ZHT181, ZAT281, YET062
YCT061, XLT062, XFT112

A recent review of Fresenius Kabi’s original submission documents for the above mentioned sets revealed that the application for their use in the US was never approved by the FDA. As a result, these sets are not in compliance with FDA regulations or registrations.Fresenius Kabi, LLC
Redmond, Washington

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