Elelyso (taliglucerase alfa) for injection, 200 units/vials,, 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/vials, due to loose metal ferrule crimps on the vials. The problem involves the entire cap either lifting or dislodging when patients or healthcare providers attempt to flip off the orange plastic button, creating a lack of assurance of sterility. A total of 24,714 vials across multiple lot numbers with expiration dates ranging from February 2020 to October 2020 were distributed nationwide in the United States and internationally to Albania, Israel, Serbia, Macedonia, Afghanistan, Botswana, South Africa, Zimbabwe, India, Rwanda, Uruguay, and Mongolia.
The recall record does not specify a remedy or instructions for affected consumers or healthcare providers.
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: Nationwide within the United States and Albania, Israel, Serbia, Macedonia, Afghanistan, Botswana/South Africa/Zimbabwe, India, Israel, Rwanda, Uruguay, Mongolia Quantity: 24,714 vials Lot/code info: Lot #: X14209, Exp. Date 02/2020; AH4601, Exp. Date 03/2020; AH4603, X46389, X78365, AT2927, Exp. Date 04/2020; AH4602, Exp. Date 05/2020; AL8590, Exp. Date 10/2020
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.