Fomepizole Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
What was recalled
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
- Recalling firm
- Navinta LLC
- NDC code
- 0781-3182-73
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0431-2015
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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