FDA-Drug2015-03-25Class II

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

Heritage Pharmaceuticals, Inc.
Hazard

Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.

Sold states
Nationwide
Affected count
24,344 vials
Manufactured in
12 Christopher Way, Suite 300, Eatontown, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0416-2015

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