Thursday, May 17, 2007

Recent reports of black particles after reconstitution of Myozyme

From Health Canada:
Genzyme has received isolated complaints pertaining to an observation of black gelatinous particles after reconstitution of 50 mg vials of Myozyme® (alglucosidase alfa). Working in close consultation with relevant regulatory authorities, Genzyme immediately initiated an investigation and discovered that when certain types of needles are used to penetrate the rubber stopper on Myozyme vials, black gelatinous particles may appear in the product, on the stopper or on the needle. Although we have not received similar complaints with Genzyme's other products, we are writing to alert our customers to the potential that such particles might appear and to provide current advice and recommendations. ...more

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