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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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7 years 11 months ago #54133 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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