D-0005-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 10, 2018
- Initiation Date
- September 19, 2018
- Termination Date
- June 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,416 vials
Product Description
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
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 Pattern
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.
Code Information
Lot S91616