Pantoprazole Sodium for Injection 40mg per vial — Class II drug recall D-1148-2023
Terminated recall by BE PHARMACEUTICALS AG, reported 2023-09-20, distributed nationwide. Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
| Recall number | D-1148-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BE PHARMACEUTICALS AG, Zug, Switzerland |
| Recall initiated | 2023-09-05 |
| Classified | 2023-09-11 |
| Reported by FDA | 2023-09-20 |
| Terminated | 2025-04-08 |
| Distributed | Nationwide (US) |
| Quantity | 41,148 vials |
| Reason classes | sterility, packaging |
| NDC | 71839-0122, 71839-0122-01, 71839-0122-10, 71839-0122-25 |
| Lot numbers | APR-2024, APRIL-2024, FEB-2025, GSC04002A, GSC04003A, GSC04004A, GSC04005A, GSC04006A, GSC05001A, GSC05006A, GSC05007A, GSC05009A, GSC06003A, GSC06004A, GSC06005A, GSC07001A, GSC07006A, GSC07007A, GSC07008A, GSC07009A, GSC08001A, GSC08002A, GSC10001A, GSC10003A, GSC10005A, GSD02012A, GSD03005A, GSD03008A, JAN-2025, JUL-2024, JUN-2024, MAR-2024, MAY-2024, SEP-2024 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1148-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.