Genzyme Recalls Transplant Drug in Further Setback
In what marks yet another manufacturing problem for the biotechnology company, Genzyme Corp. voluntarily recalled more than 10,000 vials of Thymoglobulin, a drug used during kidney transplants.
According to the FDA, the recalled batches of Thymoglobulin appeared to be cloudier, when liquefied, than the form approved by the agency. When liquid is added, the drug should only be slightly cloudy, the agency said.
The FDA has directed consumers to discontinue use of the drugs immediately from the recalled lots and to return the vials to Genzyme. The company said that most of the product has now been consumed.
According to Mr. Piela, the recalled drug was made at the same factory in France. The company has been working with the FDA to address the manufacturing issues and Genzyme had uncovered the latest problem.
A spokesman for Genzyme, of Cambridge, Mass., Bo Piela, said there were no safety threats or efficacy issues involving the recalled vials. He added that the product had been manufactured in the first half of 2007.
Thymoglobulin is made from rabbit protiens and is freeze-dried. They are administered by injection to patients undergoing kidney transplants, to prevent the patient from rejecting the transplanted organ. In 2007, the sales of Thymoglobulin reached $166 million.
In September, the FDA issued a warning letter saying the company had violated the agency's manufacturing rules at a Lyon, France, plant making Thymoglobulin. The warning letter listed violations that had occurred no several occasions and noted that the company's investigations into adverse events were 'inadequate.'
