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DATE RECALL INITIATED:
June 24, 2004
LOT NUMBER / EXPIRATION DATE:
LE08D030AA 3/30/2006
MANUFACTURER:
Baxter SA
Lessines, Belgium
REASON:
There has been an increased frequency of adverse event reports of allergic reactions associated with this lot. Although none of these reactions have been life threatening, two reported reactions involved the airway, and all reactions required medical intervention. The firm requests the use of this lot be immediately discontinued, and the affected product be returned to the manufacturer.
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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