Drug 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
D-0416-2015
Product summary
- Event
- Event 70592
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24,344 vials
- Official record key
drug-enforcement:D-0416-2015
Official wording
Reason: Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Code information: Lot # VRIA002; Exp. 08/16, VRIA003; Exp. 09/16, VRIA004; Exp. 09/16
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility