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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
Octapharma USA, Inc.
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 Platelet Disorder Support Association does not provide medical advice or endorse any medication, vitamins or herbs. The information contained herein is not intended nor implied to be a substitute for professional medical advice and is provided for educational purposes only. Always seek the advice of your physician or other qualified healthcare provider before starting any new treatment, discontinuing an existing treatment and to discuss any questions you may have regarding your unique medical condition.
Platelet Disorder Support Association 8751 Brecksville Road, Suite 150, Cleveland, Ohio 44141 Phone: 1-87-PLATELET | 877-528-3538 (toll free) | or 440-746-9003 E-mail: email@example.com