FDA Drug recall D-0540-2023
Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methapharm, Inc
- FDA Drug
- Class II
- completed
- Published 2023-05-03
On 2023-05-03 the FDA classified a Class II recall of Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methapharm, Inc by Methapharm, citing CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0540-2023 |
| Classification | Class II |
| Status | completed |
| Initiated | 2023-04-07 |
| Published | 2023-05-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Methapharm |
| Distribution | US |
Product
Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methapharm, Inc. Coral Springs, FL, 33065, NDC 67850-150-10 (carton), NDC 67850-150-00 (vial).
Reason
CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Identifiers
| code_info | Lots: 220801; 220802; 220803 Exp. July 2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0540-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.