FDA recall D-1148-2023

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.

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2023-09-05

Report date

2023-09-20

Termination date

2025-04-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Zug, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1148-2023