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Navinta recalls
FDA enforcement reports naming Navinta LLC as the recalling firm.
Recall reports
1
Class I (serious)
0
Most recent report
Apr 15, 2015
All
1
Food
0
Drugs
1
Severity
All classes
Class I: serious
Class II: moderate
Class III: low
Date
Product
Reason
Class
Apr 15, 2015
Fomepizole Injection, 1
Drug ยท Navinta LLC
Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
Class II
