Class II
Terminated
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
- Company
- Pfizer Inc.
- Recall Initiated
- February 27, 2020
- Posted
- March 11, 2020
- Recall Number
- D-0995-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 24,714 vials
- Firm Location
- New York, NY, United States
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
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
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