Biopharmaceutical Medication Recalled

Sterility concerns have prompted Pfizer Inc. to issue a voluntary recall for nearly 25,000 vials of Elelyso (taliglucerase alfa) for injection. According to the March 11, 2020, US Food and Drug Administration (FDA) Enforcement Report, customers have reported loose metal crimps on vials.

The recall affects Elelyso for injection, 200 units/vial (NDC 0069-0106-01) from lots X14209 (Exp. 2/20); AH4601 (Exp. 3/20); AH4603, X46389, X78365, and AT2927 (Exp. 4/20); AH4602 (Exp. 5/20); and AL8590 (Exp. 10/20). The product was distributed throughout the United States and in several other countries. 

Pfizer initiated the recall February 27, 2020. On March 5, 2020, the FDA designated the recall Class II, communicating use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm. 

Available with a prescription, Elelyso is a recombinant glucocerebrosidase used to treat Gaucher's disease.

—Jolynn Tumolo