Rifampin for Injection — Class II drug recall D-0774-2022
Terminated recall by Mylan Pharmaceuticals Inc, reported 2022-04-27, distributed nationwide. Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound
| Recall number | D-0774-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc, Morgantown, WV, United States |
| Recall initiated | 2022-04-07 |
| Classified | 2022-04-15 |
| Reported by FDA | 2022-04-27 |
| Terminated | 2023-05-23 |
| Distributed | Nationwide (US) |
| Quantity | 33,893 vials |
| Reason classes | specification failure |
| NDC | 67457-0445, 67457-0445-60 |
| Lot numbers | 7008990, 7009025, 7009085, 7009086, APR-2023, DEC-2022, FEB-2023 |
Product
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
Reason for recall
Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
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-0774-2022. 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.