Genzyme Drugs Contaminated With Steel, Rubber

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Elizabeth Lopatto
November 13, 2009

[efoods]Batches of Genzyme Corp.’s treatments for rare genetic disorders may be contaminated with steel fragments, non-latex rubber, and fiber-like materials from the manufacturing process, according to U.S. regulators.

Medicines affected include Cerezyme, Genzyme’s biggest selling product, as well as Fabrazyme, Myozyme, Aldurazyme, and Thyrogen. The Cambridge, Massachusetts-based company’s shares declined the most in three months in Nasdaq trading.

The contaminated drugs were made at the Allston Landing Plant in Boston, said Food and Drug Administration spokeswoman Karen Riley in a telephone interview. The plant was closed in June after being infected with a germ known as Vesivirus. The Allston plant is the primary factory for Cerezyme and Fabrazyme, and its closure has caused a shortage of both treatments.

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