Colistimethate Sodium Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 23155-193
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Colistimethate Sodium (NDC 23155-193). A significant event, classified as Class II, was initiated on Feb 25, 2015 by Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Feb 25, 2015
Mar 25, 2015
N/A
Recall Profile & Regulatory Data
Event ID
70592
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Heritage Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 26, 2016
Product Description
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
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
23155-193-41Product
23155-193-31Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
