Elelyso for injection recalled over sterility concerns

Recall date

September 19, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Pfizer Inc. recalls Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only, Distributed by Pfizer Labs, Divis…

Recall number

D-0005-2019

FDA classification

Class II

Brand / firm

Pfizer Inc.

Sold / distributed

U.S.A. nationwide. The following countries received product from Lot S91616: Albania, South Africa, Israel, Afghanistan, Rwanda, Botswana, Zimbabwe and Iraq as part of the Compassionate Use Program.

Why it was recalled

Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-0106-01