drugs Class II Updated 2015-04-15

Navinta LLC recalls Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous

Recalled 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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: VFMA 029, VFMA 030, VFMA 031, VFMA 032 Exp 4/15; VFMA 033, Exp 7/2016; VFMA 034, Exp 10/2017.
View official government recall

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