Rifampin for Injection — Class II drug recall D-0139-2020
Terminated recall by Mylan Laboratories Limited (Sterile Products Division), reported 2019-10-16, distributed nationwide. Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which cou
| Recall number | D-0139-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Laboratories Limited (Sterile Products Division), Bangalore, N/A, India |
| Recall initiated | 2019-10-07 |
| Classified | 2019-10-10 |
| Reported by FDA | 2019-10-16 |
| Terminated | 2023-03-09 |
| Distributed | Nationwide (US) |
| Quantity | 19,165 vials |
| Reason classes | specification failure |
| NDC | 67457-0445, 67457-0445-60 |
| Lot numbers | 7008334, 7008417 |
| Expiration dates | 2020-04-20, 2020-10-20 |
Product
Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.
Reason for recall
Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.
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-0139-2020. 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.