Baxter Recalls GammaGard Liquid

Baxter BioScience of Westlake Village, California, has issued a market withdrawal of its <"">GammaGard Liquid, which is the intravenous form of its Immune Globulin. The withdrawal was initiated on May 27, 2010, the U.S. Food and Drug Administration (FDA) just announced.

The GammaGard Liquid, Immune Globulin Intravenous (Human) involved includes the following product codes, lot numbers, NDC numbers, and Expiration Dates:

• Lot Number LE12J370AB, Product Code 1500185, NDC Number 0944-2700-06, and Expiration Date November 21, 2012.
• Lot Number LE12J379AB, Product Code 1500187, NDC Number 0944-2700-05, and Expiration Date November 29, 2012.

The FDA explained that this voluntary market withdrawal is being conducted as a precautionary measure due to an increased number of adverse event reports of allergic reactions associated with these two lots. Customers are asked to complete the Urgent Market Withdrawal Instructions.

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.

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