12 recalls on record
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Superpotent drug
Failed Dissolution Specifications: low dissolution results
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit