Drugs
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Recall of Collagenase (Santyl Ointment) - (Advance Biofactures Corp) - 8/22/2001
DATE RECALL INITIATED:
August 22, 2001
LOT NUMBER / EXPIRATION DATE:
3490 1047 11/2002
MANUFACTURER:
Advance Biofactures Corporation
Lynbrook, New York 11563
DISTRIBUTOR
Knoll Pharmaceutical Company
Whippany, NJ
REASON:
Product found to be below the potency specification during stability testing at 43 months. 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.
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