Dextroamphetamine Saccharate
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
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Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Presence of particulate matter in solution - black and transparent particles
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking.
Non-Sterility
Non-Sterility
Non-Sterility
Non-Sterility
Non-Sterility
An extraneous peak was observed for dissolution testing.