FDA recall D-0431-2015

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-03-09

Report date

2015-04-15

Termination date

2017-04-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ewing, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0431-2015