FDAFDA · Food and drugs·Recall number D-0005-2019
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
Published October 10, 2018 · Recall initiated: September 19, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ELELYSO
- Manufacturer
- Pfizer Inc.
- Distributor
- 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
- Lot S91616
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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