Recalls / Class II
Class IID-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
- Brand name
- Colistimethate Sodium
- Generic name
- Colistimethate Sodium
- Active ingredient
- Colistimethate Sodium
- Route
- Intramuscular, Intravenous
- NDC
- 23155-193
- FDA application
- ANDA202359
- Affected lot / code info
- 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
Why it was recalled
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Recalling firm
- Firm
- Heritage Pharmaceuticals, Inc.
- Manufacturer
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 12 Christopher Way, Suite 300, Eatontown, New Jersey 07724-3330
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-02-25
- FDA classified
- 2015-03-17
- Posted by FDA
- 2015-03-25
- Terminated
- 2016-02-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0415-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.