Vaccines, Blood & Biologics

2010 Biologics Recalls

Date
Notification
Brand NameProduct DescriptionReason/ProblemCompany
12/17/2010FLUVIRIN (Influenza Virus Vaccine) 2010-2011Formula Multidose Vials
Lot # 111812P1
Cracks in the vial necks carry the potential risk of product sterility being compromisedNovartis Vaccines and Diagnostics, Inc.
Cambridge, MA 01239
12/3/2010Rhо(D) Immune Globulin (Human) RhoGAM and MICRhоGAM Ultra-Filtered PLUSLots: RVP157A1 and RVP158A1To inform customers of a recent change in pH specification range.Ortho Clinical Diagnostics
Raritan, New Jersey
12/2/2010PK7300 Reagent ProbesPK7300 Automated Microplate SystemUnused reagent probes may drip waterBeckman Coulter, Inc.
Brea, California
11/23/2010ABBOTT PRISM Reaction TraysLot Number:
89898M500, 90044M500, 90359M500, 90579M500
List Number: 05A07-01
Customer complaints for an increase in the number of drain time (DT) error codes when using ABBOTT PRISM HBsAg (List Number 06D19) and ABBOTT PRISM HIV O Plus (List Number 03L68) assays and the ABBOTT PRISM Reaction Tray lotsAbbott Laboratories
Abbott Park, Illinois
11/22/2010Rhо(D) Immune Globulin (Human) MICRhоGAM Ultra-Filtered PLUSLot Number: MVP105A1
Package Size: 25 syringe, 5 syringe and 1 syringe.
Recent change in pH specification range from 6.20 - 6.55 to 6.20 - 7.00Ortho Clinical Diagnostics
Raritan, New Jersey
9/29/2010Level 1 Normothermic I.V. Fluid Administration SetsLevel 1 Fast Flow Fluid WarmersThe heat exchanger assemblies in these Disposable Sets may be too long and therefore, may not fitSmiths Medical ASD, Inc.
Rockland, MA
9/23/2010Octagam [Immune Globulin Intravenous (human)] 5% Liquid Preparation This was performed as a result of an increased number of reported thromboembolic events, some of which were seriousOctapharma USA, Inc.
Hoboken, NJ
9/3/2010Abbott Prism HIV O PlusPRISM -HIV-1 Group O Positive Assay Control (2) (Symbol: OPC) is out of specification high.Customers who have an alternate lot of Abbott Prism HIV O Plus are asked to discontinue use of lot 87334M500 and discard remaining inventory.Abbott Laboratories
Abbott Park, Illinois
8/20/2010OCTAGAM [Immune Globulin Intravenous (human)] 5% Liquid PreparationNumber of reported thromboembolic events, some of which were seriousOctapharma USA, Inc.
Hoboken, New Jersey
8/16/2010Influenza A (H1N1) 2009 Monovalent Vaccine
National Drug Code (NDC) 49281-640-15
5mL Multidose VialsInforms health care professionals that all lots of Influenza A (H1N1) 2009 Monovalent Vaccine in multidose vials distributed by Sanofi Pasteur in the U.S. will have a shorter expiration period than indicated on the label.Sanofi Pasteur
Swiftwater, PA
7/27/2010Verax Biomedical Platelet PGD Test Devices, P100TPlatelet PGD Test DevicesThere is a potential for a false negative to occur with the use of the affected lotVerax BioMedical
Worcester, Massachusetts
7/16/2010Immucor Panoscreen lllLot Number: 24223
Expiration Date: August 20, 2010
This carries an increased risk of clinically significant alloantibody to go undetected and could potentially lead to a transfusion reaction or Hemolytic Disease of the Newborn.Immucor, Inc.
Norcross, Georgia
6/8/2010COBAS AMPLICOR HIV MONITOR Test, v1.5Lot Number: M02635
Catalog Number: 03155935018
Expiration Date: June 30, 2010
HIV-1 MONITOR Quantitation Standard (HIM QS) vials generate low or no absorbance signalsRoche Diagnostics Corporation
Indianapolis, Indiana
5/25/2010GammaGard Liquid, Immune Globulin Intravenous (Human)Lot Numbers: LE12J370AB, LE12J379ABA precautionary measure due to an increased number of adverse event reports of allergic reactions associated with these two lots.Baxter BioScience
Westlake Village, California
4/13/2010RabAvert Rabies Vaccine (Rabies Vaccine for Human Use) KitsRabAvert Kit Batch #458011A (Expires April, 2013)
Diluent vial batch #927011 (Expires April, 2014)
This single batch as the stopper and the metal crimp dislodge from the vial completely when removing the protective capNovartis Vaccines and Diagnostics
Marburg, Germany
3/25/2010Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Expiration Date Update These lots should be used by the date indicated in the table above regardless of the expiration date imprinted on the sprayer.MedImmune LLC
Philadelphia, PA
3/29/2010AMICUS Ancillary PL2410 Plastic Storage Container 4R23504R2350, lot number FA10A26035 is an ancillary platelet storage container Lot FA10A26035
Expiration January 31, 2010
Received reports of leaks on the seals at the end of the tubing leads used to connect to the Amicus disposable kit.Baxter Fenwal Division
Dominican Republic
3/22/2010Prevnar, Pneumococcal 7-valent Conjugate Vaccine0.5 mL single dose pre-filled syringe (10 per package)Syringes to have been distributed with a rubber formulation in the syringe tip caps that was not approved for use with PrevnarWyeth
Pearl River, New York
2/26/2010Chiron RIBA HCV 3.0 SIA Customers reporting false positive assay results when using the Chiron RIBA HCV 3.0 SIA (Strip Immunoblot Assay).Novartis Vaccines and Diagnostics
Emeryville, CA
2/3/2010Influenza A (H1N1) 2009 Monovalent VaccinePrefilled Syringes UT023AA, UT023BA, UT023CA, UT023EA, UT023FAPrefilled syringes after routine stability testing determined that those lots no longer met the potency specificationSanofi Pasteur
Swiftwater, PA
1/7/2010Y-Type Blood Solution Sets Blood filter devices contained fiber-like particulate matter consistent with filter material, in the fluid path below the filter. This particulate matter has the potential to be infused into patients.Baxter
Round Lake, IL
1/7/2010Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Expiration Date Update Expiration period than that indicated on the label.MedImmune
Philadelphia, PA

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