Navinta LLC recalls Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx only, Manufactured by: Emcure Pharmaceuti
Recalled April 15, 2015 · FDA recall D-0431-2015 · Navinta
Hazard
Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility. · FDA Class II
Units
14,628 units
Sold at
Nationwide
Description
Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
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
Manufacturer(s)
Navinta LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →