Vaccines, Blood & Biologics

2013 Biologics Recalls

Date
Notification
Brand Name Product Description Reason/Problem Company
12/19/2013 Recall of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] Lot J007354 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (Merck) is initiating a voluntary recall due to the potential for a limited number of vials to contain glass particles. This lot was distributed by Merck between August 20, 2013 and October 9, 2013. No other distributed lots of Merck product are affected. Merck Sharp & Dohme Corporation
West Point, PA
12/2/2013 Notification of Voluntary Market Recall of MENVEO lot # M12115 Lot # M12115 (Men A vial Lot # A12115 and Men CWY vial lot # X12115) Novartis Vaccines is implementing a voluntary market recall of one lot of MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197 Conjugate Vaccine. This precautionary and voluntary action is being taken following observation of higher-than-specified levels of residual moisture within the lyophilized MenA component vial in the lot noted above. Novartis Vaccines and Diagnostics, Inc.
Rosia, Italy
7/3/2013 Notification of Voluntary Market Recall of MENVEO lot # M12118 Lot # M12118 (Men A vial Lot # A12118 and Men CWY vial lot # X12118) Novartis Vaccines is implementing a voluntary market recall of one lot of MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197 Conjugate Vaccine. This precautionary and voluntary action is being taken following observation of higher-than-specified levels of residual moisture within the lyophilized MenA component vial in the lot noted above. Novartis Vaccines and Diagnostics, Inc.
Rosia, Italy
6/26/2013 Recall of RECOMBIVAX HB [Hepatitis B Vaccine (Recombinant)] Lot Number J001183 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (Merck), is initiating this voluntary recall due to the potential for a limited number of cracked vials to be present in the lot. The lot was distributed by Merck between March 12, 2013 and May 2, 2013. Merck Sharp & Dohme Corporation
West Point, PA
4/26/2013 Urgent - Medical Device Recall - Trima Accel Automated Blood Collection System Catalog Number: 81000
Serial Numbers: All
Terumo BCT is voluntarily recalling the Trima Accel system for the addition of a safety enhancement called Air Reduction Mitigation (ARM). Terumo BCT, Inc.
Lakewood, Colorado
4/24/2013 Urgent Product Recall - Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK Unit Product Code 4R1584
Lot Number: FM13A15027
Fenwal has initiated a voluntary Urgent Product Recall of one lot (FM13A15027) of product code 4R1584, Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK unit. Fenwal
Lake Zurich, IL
4/18/2013 Field Correction - ALBAcyte Antibody Screening Cells Product Code Z451U
Lot Number V133096
After shipment, it was discovered that there was a mistake in the antigen profile prepared and shipped with ALBAcyte Antibody Screening Cells, product code Z451U, lot number V133096, expiring on May 20, 2013. Quotient Biodiagnostics Inc.
Newtown, Pennsylvania
4/9/2013 Urgent Biological Product Notification Seraclone Anti-S Catalog Number 808052100
Lot #8136070-01, Expiration Date August 29, 2013
Lot # 8203120-01, Expiration Date January 9, 2014
Bio-Rad Laboratories is notifying customers that ongoing stability testing of Seraclone Anti-S product has shown a decreased reactivity in lot numbers 8136070-01 and 8203120-01. Bio-Rad Laboratories, Inc.
Redmond, Washington
4/2/2013 Urgent - Drug Recall - BIVIGAM Immune Globulin Intravenous (Human),10% Liquid, 100 mL sterile vial Lot # 120016
Expiration Date: March 31, 2014
During a routine annual reserve inspection, visible particles were observed in the above lot number of BIVIGAM Immune Globulin Intravenous (Human), 10% Liquid. Biotest Pharmaceuticals Corporation
Boca Raton, FL
3/1/2013 Urgent Field Safety Notice (10699578) OpenGene DNA Sequencing System MicroCel 500 and MicroCel 300 Buffer Chamber Possible Hazard MicroCel 500 buffer chamber
Part Number 10312319/VG 42115
Manufacture Date Code Range: Dec-03-09-xx to Aug-02-10-xx

MicroCel 300 buffer chamber
Part Number 10319937/ VG 42044
Manufacture Date Code Range: Feb-02-10-xx to Jul-07-10-xx

 

Some of these buffer chambers may have the potential to leak buffer when in use. Siemens Healthcare Diagnostics, Inc.
Berkeley, CA
2/21/2013 Urgent Medical Device Recall / Field Safety Notice - Micro SSP DNA Typing Trays Multiple Identification Numbers Null allele information on the lot specific documents for these products is incorrect and may cause a mis-assignment. One Lambda, Inc.
Canoga Park, CA
2/7/2013 Update To Urgent Product Correction Notification - Incomplete Foil Seal on Specific Lots of MTS™ Anti-IgG Cards MTS084024 Ortho-Clinical Diagnostics, Inc. (OCD) issued a follow up to a previous Urgent Product Correction Notification dated November 5, 2012 regarding complaints of an incomplete foil seal for specific lots of ID-Micro Typing System Gel Cards. Micro Typing Systems
Pompano Beach, FL
2/1/2013 Update To Urgent Product Correction Notification Incomplete Foil Seal on Specific Lots of MTS A/B/D Monoclonal and Reverse Grouping Card MTS080515 Ortho-Clinical Diagnostics, Inc. (OCD) issued a follow up to a previous Urgent Product Correction Notification dated November 5, 2012 regarding complaints of an incomplete foil seal for specific lots of ID-Micro Typing System Gel Cards. Micro Typing Systems
Pompano Beach, FL

 

Page Last Updated: 08/18/2014
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