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 # VCOA002Exp. 09/14VCOA003Exp. 10/14VCOA004Exp. 10/14 VCOA005Exp. 01/15VCOA006Exp 03/15VCOA007Exp 09/15VCOA008Exp. 12/15VCOA009Exp. 02/16VCOA010Exp. 10/16 VCOA011Exp. 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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