Class II · Moderate risk
Famotidine Injection in Sodium Chloride Injection
CGMP Deviations
2,357 recalls · Class II, newest first
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
Presence of particulate matter: glass and stopper piece
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Failed Dissolution Specifications
Failed content uniformity specifications.
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
CGMP Deviations:Noted during FDA inspection
CGMP Deviations:Noted during FDA inspection
CGMP Deviations:Noted during FDA inspection