FDA-Drug2015-03-25Class II

Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc. NDC 23155-193-31

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
Manufactured in
12 Christopher Way, Suite 300, Eatontown, NJ, United States
Products
Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc. NDC 23155-193-31

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0415-2015

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