Recalls / Class II
Class IID-0416-2015
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
- Affected lot / code info
- Lot # VRIA002; Exp. 08/16, VRIA003; Exp. 09/16, VRIA004; Exp. 09/16
Why it was recalled
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Recalling firm
- Firm
- Heritage Pharmaceuticals, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 12 Christopher Way, Suite 300, Eatontown, New Jersey 07724-3330
Distribution
- Quantity
- 24,344 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-02-25
- FDA classified
- 2015-03-17
- Posted by FDA
- 2015-03-25
- Terminated
- 2016-02-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0416-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.