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U.S. Department of Health and Human Services

Drugs

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Recall of Collagenase (Santyl Ointment) - (Advance Biofactures Corp) - 03/12/2001

DATE RECALL INITIATED:

March 12, 2001

LOT NUMBER / EXPIRATION DATE:

0000067143 12/2004
0000067144 12/2004

MANUFACTURER:

Advance Biofactures Corporation
Lynbrooke, NY

DISTRIBUTOR:

Knoll Pharmaceutical Company
Whippany, NJ

REASON:

Product was found to exceed the potency specification when a new activity calculation methodology was applied. The recall is being conducted only 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.