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

FDA recall notice · announced March 11, 2020 · Pfizer

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Nationwide within the United States and Albania, Israel, Serbia, Macedonia, Afghanistan, Botswana/South Africa/Zimbabwe, India, Israel, Rwanda, Uruguay, Mongolia
Lot/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
Quantity: 24,714 vials
Status: Terminated
Products in this recall event:
- 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 (D-0995-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.