Drug 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
D-0415-2015
Product summary
- Event
- Event 70592
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0415-2015
Official wording
Reason: Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Code information: 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
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility