Fomepizole Injection — Class II drug recall D-0431-2015
Terminated recall by Navinta LLC, reported 2015-04-15, distributed nationwide. Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product
| Recall number | D-0431-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Navinta LLC, Ewing, NJ, United States |
| Recall initiated | 2015-03-09 |
| Classified | 2015-04-03 |
| Reported by FDA | 2015-04-15 |
| Terminated | 2017-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 14,628 units |
| Reason classes | sterility, cgmp |
| NDC | 00781-3182-73, 00781-3182-84 |
| Expiration dates | 2016-07, 2017-10 |
Product
Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx only, Manufactured by: Emcure Pharmaceuticals Lt. for Sandoz Inc., Princeton, NJ 08540, NDC 0781-3182-73 and 0781-3182-84
Reason for recall
Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
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-0431-2015. 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.