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

Recall Number: D-0995-2020

Firm: Pfizer Inc.

Classification: Class II

Status: Terminated

Report Date: 20200311

Initiation Date: 20200227

Termination Date: 20221228

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.

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