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  5. URGENT – Voluntary Market Withdrawal – April 21, 2016: Octagam [Immune Globulin Intravenous (human)] 5% Liquid Preparation]
  1. Safety & Availability (Biologics)

URGENT – Voluntary Market Withdrawal – April 21, 2016: Octagam [Immune Globulin Intravenous (human)] 5% Liquid Preparation]

URGENT – Voluntary Market Withdrawal – April 21, 2016: Octagam [Immune Globulin Intravenous (human)] 5% Liquid Preparation]

DATE NOTIFICATION INITIATED:

April 21, 2016

PRODUCT / LOT NUMBER / Expiration:

Octagam [Immune Globulin Intravenous (human)] 5% Liquid Preparation

Lot Number K551A8441
Expiration Date: December 17, 2017

MANUFACTURER:

Octapharma USA, Inc.
Vienna, Austria

REASON:

Effective immediately, Octapharma USA Inc. is initiating a voluntary market withdrawal of Octagam 5% [Immune Globulin Intravenous (human)] 5% Liquid Preparation] that is labeled with lot number K551A8441. 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 this Octagam from this production lot.

Customers that received this product from a distributor and not directly from Octapharma, should contact the distributor 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.