Reported Mar 25, 2015 · Terminated

Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi,…

Heritage Pharmaceuticals, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Heritage Pharmaceuticals, Inc. · 12 Christopher Way · Eatontown, NJ · 07724-3330

Is this the product you have?

  • Colistimethate for Injection USP, 150 mg per vial, Rx Only
  • Manufactured byEmcure Pharmaceuticals Ltd., Hinjwadi, Pune
  • India Manufactured forHeritage Pharmaceuticals Inc. NDC 23155-193-31
Lot codes and dates
    • 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

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 26, 2016 · Data as of Sep 19, 5:03 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.