2010 Biologics Recalls

Date Notification	Brand Name	Product Description	Reason/Problem	Company
12/17/2010	FLUVIRIN (Influenza Virus Vaccine) 2010-2011	Formula Multidose Vials Lot # 111812P1	Cracks in the vial necks carry the potential risk of product sterility being compromised	Novartis Vaccines and Diagnostics, Inc. Cambridge, MA 01239
12/3/2010	Rhо(D) Immune Globulin (Human) RhoGAM and MICRhоGAM Ultra-Filtered PLUS	Lots: RVP157A1 and RVP158A1	To inform customers of a recent change in pH specification range.	Ortho Clinical Diagnostics Raritan, New Jersey
12/2/2010	PK7300 Reagent Probes	PK7300 Automated Microplate System	Unused reagent probes may drip water	Beckman Coulter, Inc. Brea, California
11/23/2010	ABBOTT PRISM Reaction Trays	Lot 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 lots	Abbott Laboratories Abbott Park, Illinois
11/22/2010	Rhо(D) Immune Globulin (Human) MICRhоGAM Ultra-Filtered PLUS	Lot 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 – 7.00	Ortho Clinical Diagnostics Raritan, New Jersey
9/29/2010	Level 1 Normothermic I.V. Fluid Administration Sets	Level 1 Fast Flow Fluid Warmers	The heat exchanger assemblies in these Disposable Sets may be too long and therefore, may not fit	Smiths Medical ASD, Inc. Rockland, MA
9/23/2010	Octagam [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 serious	Octapharma USA, Inc. Hoboken, NJ
9/3/2010	Abbott Prism HIV O Plus	PRISM -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
8/20/2010	OCTAGAM [Immune Globulin Intravenous (human)]	5% Liquid Preparation	Number of reported thromboembolic events, some of which were serious	Octapharma USA, Inc. Hoboken, New Jersey
8/16/2010	Influenza A (H1N1) 2009 Monovalent Vaccine National Drug Code (NDC) 49281-640-15	5mL Multidose Vials	Informs 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
7/27/2010	Verax Biomedical Platelet PGD Test Devices, P100T	Platelet PGD Test Devices	There is a potential for a false negative to occur with the use of the affected lot	Verax BioMedical Worcester, Massachusetts
7/16/2010	Immucor Panoscreen lll	Lot 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
6/8/2010	COBAS AMPLICOR HIV MONITOR Test, v1.5	Lot Number: M02635 Catalog Number: 03155935018 Expiration Date: June 30, 2010	HIV-1 MONITOR Quantitation Standard (HIM QS) vials generate low or no absorbance signals	Roche Diagnostics Corporation Indianapolis, Indiana
5/25/2010	GammaGard Liquid, Immune Globulin Intravenous (Human)	Lot Numbers: LE12J370AB, LE12J379AB	A precautionary measure due to an increased number of adverse event reports of allergic reactions associated with these two lots.	Baxter BioScience Westlake Village, California
4/13/2010	RabAvert Rabies Vaccine (Rabies Vaccine for Human Use) Kits	RabAvert 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 cap	Novartis Vaccines and Diagnostics Marburg, Germany
3/25/2010	Influenza 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
3/29/2010	AMICUS Ancillary PL2410 Plastic Storage Container 4R2350	4R2350, 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
3/22/2010	Prevnar, Pneumococcal 7-valent Conjugate Vaccine	0.5 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 Prevnar	Wyeth Pearl River, New York
2/26/2010	Chiron 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
2/3/2010	Influenza A (H1N1) 2009 Monovalent Vaccine	Prefilled Syringes UT023AA, UT023BA, UT023CA, UT023EA, UT023FA	Prefilled syringes after routine stability testing determined that those lots no longer met the potency specification	Sanofi Pasteur Swiftwater, PA
1/7/2010	Y-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
1/7/2010	Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Expiration Date Update		Expiration period than that indicated on the label.	MedImmune Philadelphia, PA