BE PHARMACEUTICALS AG recalls Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials
Recalled September 20, 2023 · FDA recall D-1148-2023 · BE PHARMACEUTICALS AG
Hazard
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials. · FDA Class II
Units
41,148 vials
Sold at
Nationwide in the USA
Description
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Product
Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-10; (b) 25 Single-dose vials, NDC 71839-122-25; Rx Only, Mfd. in India for and Distributed by: BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511.
Manufacturer(s)
BE PHARMACEUTICALS AG
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →