Genzyme has voluntarily recalled all remaining stock of Fabrazyme 5 mg (agalsidase beta), with batch numbers A8049H04 and A8060H01. The reason for the recall of Fabrazyme, a drug used to treat patients who have Fabry disease, is incorrect fill volumes in a small proportion of the vials supplied.
The recall is confined to the above-mentioned batches. Genzyme is not recalling other batches of 5 mg or 35 mg vials.
The recall of 5-mg Fabrazyme comes after a warning letter in March that cited a failure to update computerized production systems for the enzyme replacement treatment for Fabry disease.
Earlier this month, production at a Genzyme drug manufacturing plant in Allston Landing, MA, had been temporarily suspended because of viral contamination. There were fears that the shutdown could cause shortages of the drugs Cerezyme and Fabrazyme.
For more, see BioPharm’s previous news coverage of Genzyme
Genzyme Detects Virus Contamination of Bioreactor, Halts Production