Market Withdrawal
Octagam
DATE WITHDRAWAL INITIATED:
December 24, 2007
PRODUCT / LOT NUMBER / EXPIRATION DATE:
Octagam [Immune Globulin Intravenous (Human) 5%]
Lot Number: A732B8431
Expiration Date: August 2009
MANUFACTURER:
Octapharma USA Inc.
Vienna, Austria
REASON:
Octapharma USA Inc. has initiated a voluntary withdrawal of one lot of Octagam (Lot A732B8431). They are advising customers not to administer any product from the lot being withdrawn. No other lots of Octagam are affected by this recall. Octapharma is taking this voluntary action based on several reports related to non life-threatening allergic type skin reactions in connection with this lot.
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.