FDA Drug recall D-0416-2015
RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for:…
- FDA Drug
- Class II
- terminated
- Published 2015-03-25
On 2015-03-25 the FDA classified a Class II recall of RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for:… by Heritage Pharmaceuticals, citing lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0416-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-25 |
| Published | 2015-03-25 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Heritage Pharmaceuticals |
| Distribution | US |
Product
RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724 NDC 23155-340-31
Reason
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Identifiers
| code_info | Lot # VRIA002; Exp. 08/16, VRIA003; Exp. 09/16, VRIA004; Exp. 09/16 |
|---|
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-0416-2015%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.