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DATE RECALL INITIATED:
October 3, 2003
LOT NUMBERS / EXPIRATION DATES:
26N33W1 5/14/2006
26N34C1 5/17/2006
26N35V1 5/23/2006
26N36V1 5/23/2006
The following lots were previously reported to FDA. After further review of the information, CBER has determined that they should not be included in the firm's voluntary recall.
28N33W1 5/14/2006
26N37J1 7/24/2006
26N37P1 7/30/2006
26N37R1 8/1/2006
MANUFACTURER:
Bayer Corporation
Clayton, NC
REASON:
These lots exhibit an increased rate of adverse event reports associated with allergic reactions. These reported reactions are identified in the package insert as the type of reactions one would expect with intravenous immunoglobulin administration. Consignees have been asked to contact the manufacturer to arrange for product return.
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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