Fomepizole Injection recalled over sterility concerns

Recall date

March 9, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Navinta LLC recalls Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx only, Manufactured by: Emcure Pharmaceut…

Recall number

D-0431-2015

FDA classification

Class II

Brand / firm

Navinta LLC

Sold / distributed

Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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