Navinta Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only recall — FDA D-0431-2015
Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
Overview of recall records associated with Navinta LLC, including dates, categories and classifications where available.
Classification mix: Class II: 1.
Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
This page summarizes recall records in which the official source identifies Navinta LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.