RIFAMPIN Recall D-0774-2022
Description: Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., NDC 67457-445-60
RIFAMPIN Recall D-0774-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0774-2022 |
| Event ID | 89910 |
| Brand | RIFAMPIN |
| Generic Name | RIFAMPIN |
| Manufacturer | RIFAMPIN |
| Original Package? | 1 |
| Active Substance | RIFAMPIN |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide in the USA |
| Quantity | 33,893 vials |
| Recall Reason | Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing. |
| Drug Classification | Class II |
| Drug Code Info | 20220427 |
| Product NDC | 67457-445 |
| Product NUI | N0000175500 M0019113 |
| Pharma Class (EPC) | Rifamycin Antibacterial [EPC] |
| Pharma Class (CS) | Rifamycins [CS] |
| Recall Initiation Date | 20220407 |
| Report Date | 20220427 |
| Classification Date | 20220415 |
| Address | 3711 Collins Ferry Rd Morgantown, WV 26505-2362 United States |
| Recalling Firm | Mylan Pharmaceuticals Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | VJT6J7R4TR |
| Drug Application Number | ANDA065421 |
| Structured Product Labeling (SPL ID) | de4817e4-c300-4990-9c2b-d816917c8bb4 |
| Structured Product Labeling (SPL Set ID) | 8be91604-d7cd-4f2b-997d-e3364e4092e5 |
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