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

FDA recall notice · announced April 15, 2015 · Navinta

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide
Lot/code information: Lot #: VFMA 029, VFMA 030, VFMA 031, VFMA 032 Exp 4/15; VFMA 033, Exp 7/2016; VFMA 034, Exp 10/2017.
Quantity: 14,628 units
Status: Terminated
Products in this recall event:
- 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 (D-0431-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.