Thymoglobulin Recall: Anti-Rejection Drug May Not Be Stable

The U.S. Food and Drug Administration (FDA) posted information Tuesday about a Thymoglobulin recall for one lot of the anti-rejection drug due to stability testing which found samples to be out of specification.

The recall of thymoglobulin applies to lot number C7010C01, manufactured by Genzyme Corp, which was found during visual inspections for stability to have an appearance referred to as opalescence. The impacted lot carries an expiration date of April 2010, and consumers have been warned not to use the drug and to return any unused portions of the product to the manufacturer.

Thymoglobulin is used to reduce the risk of organ rejection in patients who have undergone kidney transplants. It functions by suppressing the immune response of the body. Neither the FDA or Genzyme Corp. posted information about specific health risks the recalled thymoglobulin could cause.

In October 2007, the FDA sent a warning letter to Genzyme regarding violations found at its biologics facility in Lyon, France. The FDA discovered a number of potential problems with quality control and with the purified water system at the plant. Although there is no indication that these violations have any connection to the current recall, the FDA did indicate that these problems could lead to impurities in Genzyme’s drugs.

At least two other thymoglobulin recalls have been issued by Genzyme Corp this year for similar stability problems. In Feburary 2008 a recall was issued for lot number CG025CAA, with an expiration date of Nov 2009, and in April 2008 a recall was issued for three additional lots (C7014C01 with expiration date May 31, 2010; C7008C01 with expiration date March 31, 2010 and TH175-05 with expiration date October 4, 2009).

All of the Genzyme recalls were initiated after the products failed periodic stability tests based on the appearance of the product. The specifications for the appearance of reconstituted Thymoglobulin solution is a clear, limpid to slightly opalescent liquid. Some of the samples from recalled lots were found to have exceeded the slightly opalescent stability specification based on visual examinations.