PANTOPRAZOLE SODIUM Recall D-0540-2023
Description: 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).
PANTOPRAZOLE SODIUM Recall D-0540-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0540-2023 |
| Event ID | 92113 |
| Brand | PANTOPRAZOLE SODIUM |
| Generic Name | PANTOPRAZOLE SODIUM |
| Manufacturer | PANTOPRAZOLE SODIUM |
| Original Package? | 1 |
| Active Substance | PANTOPRAZOLE SODIUM |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide in the USA |
| Quantity | 5377 cartons |
| Recall Reason | CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures. |
| Drug Classification | Class II |
| Drug Code Info | 20230503 |
| Product NDC | 67850-150 |
| Recall Initiation Date | 20230407 |
| Report Date | 20230503 |
| Classification Date | 20230421 |
| Address | 11772 W Sample Rd Ste 101 Coral Springs, FL 33065-3166 United States |
| Recalling Firm | Methapharm Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 6871619Q5X |
| Drug Application Number | ANDA209524 |
| Structured Product Labeling (SPL ID) | 1fda95c3-f387-46be-a975-5027b50bc173 |
| Structured Product Labeling (SPL Set ID) | b90163d1-3425-42d6-adf3-b9da0e70389a |
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