Class II
Terminated
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
- Company
- Pfizer Inc.
- Recall Initiated
- September 19, 2018
- Posted
- October 10, 2018
- Recall Number
- D-0005-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 12,416 vials
- Firm Location
- New York, NY, United States
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.
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 Info
Lot S91616
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