FDA Drug recall D-0431-2015
Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx only, Manufactured by: Emcure Pharmaceuticals Lt. for Sandoz…
- FDA Drug
- Class II
- terminated
- Published 2015-04-15
On 2015-04-15 the FDA classified a Class II recall of Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx only, Manufactured by: Emcure Pharmaceuticals Lt. for Sandoz… by Navinta, citing lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0431-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-09 |
| Published | 2015-04-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Navinta |
| Distribution | US |
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
Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
Identifiers
| code_info | Lot #: VFMA 029, VFMA 030, VFMA 031, VFMA 032 Exp 4/15; VFMA 033, Exp 7/2016; VFMA 034, Exp 10/2017. |
|---|
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-0431-2015%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.