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Drug Information Update- Information for Healthcare Professionals – Potential Contamination of Products Manufactured by Genzyme Corporation

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation byFDA.

FDA is warning healthcare professionals about the potential for foreign particle contamination of several products manufactured by Genzyme Corporation that are used to treat rare, serious, and life-threatening diseases.The foreign particles, believed to be found in less than 1% of products based on product lots assessed to date, include stainless steel fragments, non-latex rubber from the vial stopper, and fiber-like material from the manufacturing process and could potentially cause serious adverse events in patients. This problem affects all lots of the below listed products which have the prefix “A” (e.g., Lot A12345).

The affected products include:

Cerezyme (imiglucerase) for Gaucher disease – intravenous (IV) infusion 
Fabrazyme (agalsidase beta) for Fabry disease – IV infusion 
Myozyme (alglucosidase alpha) for Pompe disease – IV infusion 
Aldurazyme (laronidase) for Mucoploysaccharidosis Type I – IV infusion 
Thyrogen (thyrotropin alpha) used as an adjunctive diagnostic tool and treatment for thyroid cancer – Intramuscular (IM) injection

For more information, please visit: Genzyme


December 5, 2009 - Posted by | 1

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