FDA Drug recall D-1148-2023
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
- FDA Drug
- Class II
- terminated
- Published 2023-09-20
On 2023-09-20 the FDA classified a Class II recall of 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 by Be Pharmaceuticals Ag, citing lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1148-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-09-05 |
| Published | 2023-09-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Be Pharmaceuticals Ag |
| Distribution | US |
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
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Identifiers
| ndc | 71839-122-25 |
|---|---|
| ndc | 71839-122-10 |
| ndc | 71839-122-01 |
| code_info | Lots: (a) GSC04002A, GSC04003A, GSC04004A, GSC04006A, Exp Mar-2024; GSC05001A, GSC05006A, GSC05007A, Exp April-2024; G…Lots: (a) GSC04002A, GSC04003A, GSC04004A, GSC04006A, Exp Mar-2024; GSC05001A, GSC05006A, GSC05007A, Exp April-2024; GSC10003A, GSC10005A Exp Sep-2024;GSC06004A, GSC06005A, Exp May-2024; GSC07001A, GSC07007A, GSC07008A, GSC07009A, Exp Jun-2024; GSC08001A, Exp Jul-2024; GSC05009A, Exp Apr-2024; (b) GSC04005A, Exp Mar-2024; GSC06003A, Exp May-2024; GSC10001A, Exp Sep-2024; GSC07006A,Exp Jun-2024; GSC08002A, Exp Jul-2024; GSD02012A, Exp Jan-2025; GSD03005A, GSD03008A, Exp Feb-2025; |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1148-2023%22
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