October 12, 2018
Citing sterility concerns, Pfizer Inc. is recalling one lot of Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vials (NDC 0069-0106-01), according to the October 10, 2018, US Food and Drug Administration (FDA) Enforcement Report. The move follows reports of loose metal crimps on vials that resulted in dislodged caps.
The nationwide recall is for 12,416 vials from lot S91616. In addition to the United States, vials from the recalled lot were distributed in Albania, South Africa, Israel, Afghanistan, Rwanda, Botswana, Zimbabwe, and Iraq.
Pfizer voluntarily initiated the recall September 19, 2018. On October 2, 2018, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Elelyso is a prescription biopharmaceutical drug used to treat Gaucher's disease.
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