DATE WITHDRAWAL INITIATED:
May 27, 2010
PRODUCT / LOT NUMBER /EXPIRATION DATE:
GammaGard Liquid, Immune Globulin Intravenous (Human)
|Lot Number||Product Code||NDC Number||Expiration Date|
|LE12J370AB||1500185||0944-2700-06||November 21, 2012|
|LE12J379AB||1500187||0944-2700-05||November 29, 2012|
Westlake Village, California
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.