DATE RECALL INITIATED:
December 19, 2003
LOT NUMBER / EXPIRATION DATE
A631805 5/19/2006
MANUFACTURER:
Aventis Behring, LLC
Bradley, IL
REASON:
This lot exhibits an increased frequency of adverse event reports associated with allergic reactions. The adverse events received to date for this lot are principally hives and itching.
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.
|