FDA Drug recall D-0231-2016
RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only
- FDA Drug
- Class III
- terminated
- Published 2015-11-25
On 2015-11-25 the FDA classified a Class III recall of RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only by Akorn, citing failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0231-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-08-20 |
| Published | 2015-11-25 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Akorn |
| Distribution | US |
Product
RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.
Reason
Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
Identifiers
| code_info | Lot #: 14RIF1(A), Expiry: 9/30/2016. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0231-2016%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.