Drug recall D-0995-2020
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.
Lots and codes
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
Recall details
- Recalling firm
- Pfizer Inc., New York, NY
- Quantity
- 24,714 vials
- Distribution
- Nationwide within the United States and Albania, Israel, Serbia, Macedonia, Afghanistan, Botswana/South Africa/Zimbabwe, India, Israel, Rwanda, Uruguay, Mongolia
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 27, 2020
- Terminated
- December 28, 2022
Related products
- Elelyso – drug information
- NDC 0069-0106 Elelyso · Taliglucerase Alfa 200 U/5mL · Pfizer Laboratories Div Pfizer Inc