Class II · Moderate risk
Carvedilol 25 mg Tablet
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
FDA Drug Recalls
2 recalls, newest first
Class II · Moderate risk
Duloxetine Delayed-Release Capsules USP
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit