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

FDA recall notice · announced October 10, 2018 · Pfizer

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

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.

Notes

Distribution: 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.
Lot/code information: Lot S91616
Quantity: 12,416 vials
Status: Terminated
Products in this recall event:
- 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 (D-0005-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.