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DATE RECALL INITIATED:
July 14, 2004
LOT NUMBER / EXPIRATION DATE :
201-07-211 7/19/2006
MANUFACTURER:
Associates of Cape Cod, Inc.
Falmouth, MA
REASON:
Internal testing by Associates of Cape Cod, Inc. discovered that one lot of Pyrotell (2mL/vial, Lot # 201-07-211) showed moisture content slightly above specification. Upon discovery, the performance of this lot was re-confirmed in that the label claim (sensitivity) continues to meet specification. 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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