On April 9, 2008, Genzyme Corporation (Framingham, MA) announced a recall of three lots of its organ-rejection antibody, Thymoglobulin, because of stability concerns.
On April 9, 2008, Genzyme Corporation (Framingham, MA) announced a recall of three lots of its organ-rejection antibody, Thymoglobulin, because of stability concerns. One of the lots of Thymoglobulin failed a visual stability test. The other two lots were recalled based on a predicted stability failure prior to the labeled expiration date.
Genzyme previously had problems with Thymoglobulin in September 2007, when it received an FDA warning letter related to the company’s its Thymoglobulin bulk manufacturing operations in Lyon, France. Specific violations cited included accepting components and intermediates that exceeded bioburden and pathogenic microorganism limits.
