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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) - 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.