  
Excessive potency spurs recall of Advance Biofactures' Santyl ointment
Last Updated: 2001-05-01 15:11:25 EDT (Reuters Health)
WASHINGTON (Reuters Health) - Knoll Pharmaceutical Company, a subsidiary of Abbott Laboratories, is recalling two lots of a collagenase product made by Advance Biofactures Corporation of Lynbrooke, New York, according to a recently-released US Food and Drug Administration (FDA) enforcement report.
Santyl ointment is indicated for debriding chronic dermal ulcers and severely burned areas. The affected lots are 0000067143 and 0000067144, which have a December 2004 expiration date, the FDA said.
The product, marketed as Santyl Ointment, was found to exceed potency limits, the FDA explained. The problem was discovered when a new method for calculating its activity was applied, the agency said.
The recall began March 12 and is being conducted on the wholesale level, the FDA added.
The latest action represents the second recall of the product in less than a year. In September 2000, Advance Biofactures issued a voluntary recall of one lot of the ointment because the bulk product had failed sterility testing.
The company said late last year that it had instituted new manufacturing controls.
Shares of BioSpecifics Technologies, Advance Biofactures' parent company, were unchanged at 0.94 in Tuesday afternoon trade on the NASDAQ exchange. The company said last month that it has received notice that its shares are subject to delisting from the NASDAQ because they have failed to maintain the minimum market value.
The respective participants could not be reached for comment.
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