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DATE RECALL INITIATED:
July 20, 2001
PRODUCT / LOT NUMBER / EXPIRATION DATE:
Albumin (Human) USP, 5%, Albuminar-5, 250 mL and 500 mL
Lot Numbers and Expiration Dates - (Updated 7/26/2001)
MANUFACTURER:
Aventis Behring L.L.C.
King of Prussia, PA
REASON:
Stoppers supplied by the vendor exhibited an anomaly that could potentially compromise the sterility of the product. The firm has received one adverse event report which may be associated with the administration of one of the recalled lots. Customers were asked to examine their stock of Albuminar-5, and return all recalled lots.
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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