Drug 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.
Lots and codes
Lot # VCOA002; Exp. 09/14, VCOA003; Exp. 10/14, VCOA004; Exp. 10/14 VCOA005; Exp. 01/15, VCOA006; Exp 03/15, VCOA007; Exp 09/15, VCOA008; Exp. 12/15, VCOA009; Exp. 02/16, VCOA010; Exp. 10/16 VCOA011; Exp. 10/16
Recall details
- Recalling firm
- Heritage Pharmaceuticals, Inc., Eatontown, NJ
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 25, 2015
- Terminated
- February 26, 2016
Related products
- Colistimethate Sodium – drug information
- NDC 23155-193 Colistimethate Sodium · Colistimethate Sodium 150 mg/4mL · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.