Colistimethate Injection 150mg (Heritage) – Sterility Concerns (2015)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Heritage Pharmaceuticals, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Heritage Pharmaceuticals, Inc. is recalling Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals due to Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026