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  5. URGENT – Voluntary Market Withdrawal – October 13, 2017: octagam [Immune Globulin Intravenous (human)] 10% Liquid Preparation]
  1. Recalls (Biologics)

URGENT – Voluntary Market Withdrawal – October 13, 2017: octagam [Immune Globulin Intravenous (human)] 10% Liquid Preparation]

DATE NOTIFICATION INITIATED:  October 13, 2017

PRODUCT / LOT NUMBER / Expiration:

Octagam [Immune Globulin Intravenous (human)] 10% Liquid Preparation

Lot Numbers:  K724B8541 & K725A8541
Expiration Dates:  K724B8541 (June 14, 2019) & K725A8541 (June 23, 2019)

MANUFACTURER: 

Octapharma Pharmazeutika Produktionsges.m.b.H.
Vienna, Austria

REASON:

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.  Although there have been no reports of serious injury at this time, Octapharma has determined, through consultation with the public health authorities at FDA, the most prudent course of action is to suspend further administration of octagam 10% from these particular production lots.

Distributors that received these lots of octagam 10% from Octapharma are asked to immediately quarantine these lots and contact Octapharma for return instructions.


The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.