Colistimethate for Injection USP — Class II drug recall D-0415-2015
Terminated recall by Heritage Pharmaceuticals, Inc., reported 2015-03-25, distributed nationwide. Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control
| Recall number | D-0415-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heritage Pharmaceuticals, Inc., Eatontown, NJ, United States |
| Recall initiated | 2015-02-25 |
| Classified | 2015-03-17 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2016-02-26 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| NDC | 23155-0193, 23155-0193-31, 23155-0193-41 |
| Lot numbers | 01/15, 02/16, 03/15, 09/14, 09/15, 10/14, 10/16, 12/15, VCOA002, VCOA003, VCOA004, VCOA005, VCOA006, VCOA007, VCOA008, VCOA009, VCOA010, VCOA011 |
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 for recall
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0415-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.