Reported Mar 11, 2020 · Terminated
Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by Pfizer Labs, Division of Pfizer…
Pfizer Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pfizer Inc. · 235 E 42nd St · New York, NY · 10017-5703
Is this the product you have?
- 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
- Lot codes and dates
Lot #: X14209Exp. Date 02/2020AH4601Exp. Date 03/2020AH4603X46389X78365AT2927Exp. Date 04/2020AH4602Exp. Date 05/2020AL8590Exp. Date 10/2020
- Amount recalled
- 24,714 vials
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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