FDA recall D-0415-2015

Product

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-02-25

Report date

2015-03-25

Termination date

2016-02-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Eatontown, NJ, United States

Primary source

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