Pantoprazole Sodium for Injection 40mg per vial recalled over sterility concerns

Recall date

September 5, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

BE PHARMACEUTICALS AG recalls Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vial…

Recall number

D-1148-2023

FDA classification

Class II

Brand / firm

BE PHARMACEUTICALS AG

Sold / distributed

Nationwide in the USA

Why it was recalled

Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.