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
Reported: March 25, 2015 Initiated: February 25, 2015 #D-0416-2015
Product Description
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 for Recall
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Details
- Recalling Firm
- Heritage Pharmaceuticals, Inc.
- Units Affected
- 24,344 vials
- Distribution
- Nationwide
- Location
- Eatontown, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Heritage Pharmaceuticals, Inc.. Units affected: 24,344 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 25, 2015. Severity: Moderate. Recall number: D-0416-2015.
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