# FDA recall D-0431-2015

> **Navinta LLC** · Class II · drug recall initiated 2015-03-09.

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0431-2015
- **Recalling firm:** Navinta LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-03-09
- **Report date:** 2015-04-15
- **Termination date:** 2017-04-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ewing, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0431-2015

## Citation

> AI Analytics. FDA recall D-0431-2015. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0431-2015. Source: US FDA. Licensed CC0.

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