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10/5/2001

FDA Announces New Collagenase Recall

Kate Traynor

For the third time this year, the Food and Drug Administration (FDA) has announced a recall of specific lots of collagenase manufactured by Advance Biofactures Corp. and sold as Santyl Ointment.

Lots 0000074200, 0000074201, and 0000071342, all bearing the expiration date 1/2005, have been found to exceed potency specifications and are being recalled at the wholesale level.

Last month, FDA announced a wholesale-level recall of lot 3490 1047 of the product. According to FDA’s Center for Biologics Evaluation and Research, 43-month stability testing of this batch of collagenase showed that it had a lower potency than required by specifications.

Earlier this year, two lots of Santyl Ointment were recalled because they exceeded potency specifications. Last August, one lot of the product was recalled because it was found to be unsterile.

Santyl is distributed by Abbott Laboratories, which acquired the product when the company purchased Knoll Pharmaceutical Co. earlier this year.