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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) - 10/1/2001

DATE RECALL INITIATED:

October 1, 2001

LOT NUMBER / EXPIRATION DATE:

0000074200 1/2005
0000074201 1/2005
0000071342 1/2005

MANUFACTURER:

Advance Biofactures Corporation
Lynbrook, New York 11563

DISTRIBUTOR

Knoll Laboratories
Mount Olive, NJ 07828

REASON:

Product found to be above the potency specification during stability testing. 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.