Colistimethate for Injection USP recalled over sterility concerns
- Recall date
- February 25, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Heritage Pharmaceuticals, Inc. recalls Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pun…
- Recall number
- D-0415-2015
- FDA classification
- Class II
- Brand / firm
- Heritage Pharmaceuticals, Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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