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
Check against the official notice below — it lists the full affected range.
Pfizer Inc. is recalling Elelyso (taliglucerase alfa) for injection, 200 units/vial, due to loose metal ferrule crimps on the vials. Reports indicate that the entire cap either lifted or dislodged when users attempted to remove the orange plastic button, creating a potential sterility concern. The recall affects 12,416 vials from Lot S91616 that were distributed nationwide in the United States, as well as vials distributed to Albania, South Africa, Israel, Afghanistan, Rwanda, Botswana, Zimbabwe, and Iraq through a Compassionate Use Program.
The recall notice does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Quantity: 12,416 vials Lot/code info: Lot S91616
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.