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

Recall Number: D-0415-2015

Firm: Heritage Pharmaceuticals, Inc.

Classification: Class II

Status: Terminated

Report Date: 20150325

Initiation Date: 20150225

Termination Date: 20160226

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

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