💊 Drugs • 11,927 recalls
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Out of Specification for Dissolution
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Superpotent; sodium benzoate preservative
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Failed Dissolution Specifications.
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
Astellas Pharma US
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Amerisource Health Services
Failed Dissolution Specifications:
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.