Pantoprazole sodium for Injection 40 mg*/vial — Class II drug recall D-0540-2023
Completed recall by Methapharm Inc, reported 2023-05-03, distributed nationwide. CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which d
| Recall number | D-0540-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Methapharm Inc, Coral Springs, FL, United States |
| Recall initiated | 2023-04-07 |
| Classified | 2023-04-21 |
| Reported by FDA | 2023-05-03 |
| Distributed | Nationwide (US) |
| Quantity | 5,377 cartons |
| Reason classes | cgmp |
| NDC | 67850-0150-00, 67850-0150-10 |
| Lot numbers | 220801, 220802, 220803 |
| Expiration dates | 2024-07-20 |
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 for recall
CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
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-0540-2023. 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.