FDA Drug Safety Communication

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, nonlatex 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 that have the prefix "A" (eg, Lot A12345).

Potential adverse events from IM administration of a contaminated product could include local pain, swelling, and inflammation. Potential adverse reactions from IV administration of a product contaminated with foreign particles could be more serious, including damage to blood vessels or embolic events, and anaphylactic, allergic, and immune-mediated reactions. It is also possible that the foreign particles could affect how well these products work.

This information reflects the current analysis of data available to FDA concerning this drug. FDA intends to update this communication when additional information or analyses become available.

View the full FDA Drug Safety Communication on FDA.gov