D-0995-2020 Class II Terminated
FDA drug recall D-0995-2020 was initiated by Pfizer Inc. on February 27, 2020 and is designated Class II. 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. The recall status is terminated (terminated December 28, 2022). Affected quantity: 24,714 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- March 11, 2020
- Initiation Date
- February 27, 2020
- Termination Date
- December 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24,714 vials
Product Description
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.
Distribution Pattern
Nationwide within the United States and Albania, Israel, Serbia, Macedonia, Afghanistan, Botswana/South Africa/Zimbabwe, India, Israel, Rwanda, Uruguay, Mongolia
Code Information
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