FDA Drug recall D-0139-2020
Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103
- FDA Drug
- Class II
- terminated
- Published 2019-10-16
On 2019-10-16 the FDA classified a Class II recall of Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 by Mylan Laboratories Sterile Products Division, citing failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0139-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-07 |
| Published | 2019-10-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mylan Laboratories Sterile Products Division |
| Distribution | US |
Product
Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.
Reason
Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.
Identifiers
| ndc | 67457-445-60 |
|---|---|
| code_info | Lot: 7008334, Exp April 2020; 7008417, Exp Oct 2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0139-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.