Product: 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
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.
Recall initiated: 20200227
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated