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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Market Withdrawal of Octagam-Octapharma USA Inc.

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 They are advising customers not to administer any product from the lot being withdrawn.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.

 

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(800) 835-4709
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Consumer Affairs Branch (CBER)

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Food and Drug Administration

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Rockville, MD 20852-1448