Vaccines, Blood & Biologics

2017 Biologics Recalls

Date NotificationBrand NameProduct DescriptionReason/ProblemCompany
12/15/2017Voluntary Medical Device Customer Notification – Vista Information SystemVista Information System (version 4)TERUMOBCT is notifying customers of an issue related to using Vista Information System version 4. There is a specific condition that will cause messages not to be displayed in the Product Message tab for a completed, Vista-controlled procedure on the Trima Accel Automated Blood Collection System.TERUMOBCT
Lakewood, CO
11/09/2017Product Information Advisory - Albumin Human 25% Solution (AlbuRx 25)

AlbuRx 25
50 mL and 100 mL expiring on or before May 30, 2020
 

CSL Behring noted the potential for fading print with more effect on the expiration dating on the patient tear off portion of the vial label. This is limited to 50 and 100 mL vial sizes.CSL Behring LLC
Kankakee, IL
10/13/2017URGENT – Voluntary Market Withdrawal – October 13, 2017 octagam [Immune Globulin Intravenous (human)] 10% Liquid Preparation]Lot Numbers: K724B8541 & K725A8541
Expiration Dates: K724B8541 (June 14, 2019) & K725A8541 (June 23, 2019)
Effective immediately, Octapharma USA Inc. is initiating a voluntary market withdrawal of octagam 10% [Immune Globulin Intravenous (human)] 10% Liquid Preparation] that is labeled with lot numbers K724B8541 & K725A8541.Octapharma Pharmazeutika Produktionsges.m.b.H.
7/11/2017Recall of MENVEO® [Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197Conjugate Vaccine] Solution for intramuscular injectionLot Number: M16095 Expiration Date: March 2018GlaxoSmithKline (GSK) is recalling MENVEO® [Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine] Solution for intramuscular injection 5 DOSES (10 vials) per Package lot M16095. The recall is a precautionary measure since the associated batch was subject to a mechanical intervention executed during the aseptic filling operations, which is not supported by validation data.GSK Vaccines, Srl

 

Page Last Updated: 04/05/2018
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