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PDSA Announcements
TOPIC:
Octagam Voluntary Market Withdrawal 7 years 5 months ago #54133
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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 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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