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

Recall Number: D-0431-2015

Firm: Navinta LLC

Classification: Class II

Status: Terminated

Report Date: 20150415

Initiation Date: 20150309

Termination Date: 20170410

Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.

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