Recall
of Collagenase, Santyl Ointment
DATE RECALL INITIATED:
September 20, 2002
LOT NUMBER / EXPIRATION DATE:
0000075211 2/2005
MANUFACTURER:
Advance Biofactures Corporation
Lynbrook, New York
DISTRIBUTOR:
Abbott Laboratories
Whippany, NJ
REASON:
Product found to be above the potency specification during stability testing (super-potent). The recall is being conducted to the wholesale level.
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.
Last Updated: 10/8/2002
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Updated: September 26, 2003 |