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PDSA Announcements

Octagam Voluntary Market Withdrawal

  • Jeff
  • Topic Author
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  • I am the PDSA web guy, and also help with PDSA's social media accounts, like Facebook, Twitter, Instagram, etc.
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9 years 9 months ago #54133 by Jeff
Octagam Voluntary Market Withdrawal was created by Jeff
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.

- Source: www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm497244.htm
Jeff Cooper, PDSA website guy

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Platelet Disorder Support Association

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IMPORTANT!

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.