PANTOPRAZOLE SODIUM Recall D-1104-2022
Description: Pantoprazole Sodium for Injection, 40 mg/vial, 10 single-dose vials, Rx only, MFG: Sandoz Pharma, NDC 0781-3232-95
PANTOPRAZOLE SODIUM Recall D-1104-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1104-2022 |
| Event ID | 89646 |
| Brand | PANTOPRAZOLE SODIUM |
| Generic Name | PANTOPRAZOLE SODIUM |
| Manufacturer | PANTOPRAZOLE SODIUM |
| Original Package? | 1 |
| Active Substance | PANTOPRAZOLE SODIUM |
| Drug Route | INTRAVENOUS |
| Distribution | USA nationwide. |
| Quantity | 1 carton/10 vials |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0781-3232 |
| Recall Initiation Date | 20220413 |
| Report Date | 20220615 |
| Classification Date | 20220609 |
| Address | 9954 Maryland DriveDeep Run Iii Ste. 4000 Richmond, VA 23233 United States |
| Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 6871619Q5X |
| Drug Application Number | ANDA090296 |
| Structured Product Labeling (SPL ID) | 07ae0485-8a7d-4bda-830c-a2e47c72490f |
| Structured Product Labeling (SPL Set ID) | 27c6ccc3-1041-402e-b3bc-fc779a27d584 |
| Similar To |