Butalbital
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Every FDA drug recall whose status is still Ongoing: the firm is still removing product from the market, or the FDA has not yet closed the file. Some were opened years ago and never formally terminated, so check the initiation date as well as the status.
2,760 recalls, newest first.
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Labeling: Incorrect Instructions
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Superpotent Drug
Failed Stability Specifications; out of specification for shear.
Failed Stability Specifications; out of specification for shear.
Defective container: possibility for lack of seal integrity.
Marketed without ANDA/NDA approval
Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
cGMP Deviations
Chemical Contamination: presence of benzene
Chemical Contamination: presence of benzene
cGMP Deviations