FDA Drug recall D-0415-2015

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

FDA Drug
Class II
terminated
Published 2015-03-25

On 2015-03-25 the FDA classified a Class II recall of Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufacture… by Heritage Pharmaceuticals, citing lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0415-2015
Classification	Class II
Status	terminated
Initiated	2015-02-25
Published	2015-03-25
Last updated	2026-09-13 11:51 UTC
Company	Heritage Pharmaceuticals
Distribution	US

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

Reason

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

Identifiers

ndc	23155-193-41
ndc	23155-193-31
code_info	Lot # VCOA002; Exp. 09/14, VCOA003; Exp. 10/14, VCOA004; Exp. 10/14 VCOA005; Exp. 01/15, VCOA006; Exp 03/15, VCOA007;… 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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0415-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.