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Drugs

Voluntary Recall of Collagenase, Santyl Ointment, 30 gram tube - (Advance Biofactures Corp.) - 8/28/2000

DATE RECALL INITIATED:

August 28, 2000

LOT NUMBERS / EXPIRATION DATE:

51234, 8/2004

MANUFACTURER:

Advance Biofactures Corporation
35 Wilbur Street
Lynbrook, NY 11563-2358

REASON:

Testing of the bulk ointment failed sterility testing. The lot was released because the finished product passed the sterility test. However, the source of the organism found in the bulk test sample was never identified.

 


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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