Tuesday, September 9, 2008

Genzyme recalls a batch of French-made anti-rejection drug

The U.S. Food and Drug Administration reports that Genzyme Corp. has issued a recall of a single lot of its anti-rejection drug, thymoglobulin, due to the fact that it may not be as stable as it should.

According to the FDA, Cambridge-based Genzyme (Nasdaq: GENZ) is asking to have all of Lot No. C7010C01 of the popular drug used to control rejection in transplant patients, with an expiration date of April 2010, returned to the company. The drug was made in manufacturing facilities at Genzyme Polyclonals S.A.S. in Lyon, France

The FDA warned Genzyme about violations at its biologics plant in Lyon, in October of 2007. The FDA said Genzyme had problems with, among other things, its purified water system and quality control unit at the plant. The potential problems could lead to impurities in the drug if the company does not take action, the FDA said.

The FDA warned at the time that if the company did not correct the deficiencies at the plant, the agency could initiate actions such as suspension of the license for the facility. Genzyme addressed the problems to the satisfaction of the FDA.

Since then Genzyme has recalled lots of thymoglobulin in February and again in April. The company said in its recent first quarter report that it would recall any lots that “are expected to go out of specification prior to the originally established expiry period.”

With 9,000 employees, Genzyme reported a 2007 profit of $481 million on revenue of $3.8 billion.