RIFAMPIN Recall D-0012-2023
Description: Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA, NDC 51407-322-30
RIFAMPIN Recall D-0012-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0012-2023 |
| Event ID | 90992 |
| Brand | RIFAMPIN |
| Generic Name | RIFAMPIN |
| Manufacturer | RIFAMPIN |
| Active Substance | RIFAMPIN |
| Drug Route | ORAL |
| Distribution | USA nationwide |
| Recall Reason | Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP). |
| Drug Classification | Class II |
| Drug Code Info | 20221026 |
| Product NDC | 51407-322 51407-323 |
| Product NUI | N0000175500 M0019113 |
| Pharma Class (EPC) | Rifamycin Antibacterial [EPC] |
| Pharma Class (CS) | Rifamycins [CS] |
| Recall Initiation Date | 20221006 |
| Report Date | 20221026 |
| Classification Date | 20221017 |
| Address | 5187 Camino Ruiz Camarillo, CA 93012-8601 United States |
| Recalling Firm | Golden State Medical Supply Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | VJT6J7R4TR |
| Drug Application Number | ANDA065028 |
| Structured Product Labeling (SPL ID) | dc7a8254-9cf6-4bf4-e053-2995a90a0e59 |
| Structured Product Labeling (SPL Set ID) | a112e73c-9bce-b58a-e053-2a95a90a987d |
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