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Pfizer Inc. Recall: Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use

Pfizer Inc. Recall: Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Pfizer Inc.; Product: Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only, Distributed by Pfizer Labs, Division of

Recalling firmPfizer Inc.
ProductElelyso (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
Reason for recallLack 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.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionU.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.
Recall initiated20180919
Recall numberD-0005-2019
Categorydrug
StateNY
CountryUnited States

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