Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride
Defective container
1,206 recalls · Class II, newest first
Defective container
Labeling: Label Mix-Up
CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.
Super Potent and Failed Reconstitution Time
Product found to be Sub Potent or Exceeded reconstitution time
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility