Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Nitrosamine impurities (NDMA/NDEA)
Trace nitrosamine impurities such as NDMA, NDEA or NMBA found above the acceptable daily limit. Nitrosamines are probable human carcinogens that can form during manufacturing or storage. This is the cause behind the large valsartan, losartan and ranitidine (Zantac) recalls.
568 FDA drug recalls with this cause, newest first.
Nitrosamine compounds such as NDMA, NDEA or NMBA are probable human carcinogens that can form during manufacturing or storage. Recalls here trace back to a nitrosamine found above the accepted limit - whether the report names the compound or simply calls it a 'carcinogenic impurity'. It is a newer category, driven by improved testing methods that can now detect impurities that were previously missed, and it is the chemistry behind the large valsartan, losartan and ranitidine (Zantac) recalls.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
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.
Class II · Moderate risk
Carvedilol Tablets
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Class II · Moderate risk
Carvedilol Tablets
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
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
Class II · Moderate risk
Duloxetine DR Capsules USP 60 mg
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules USP 20 mg
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules USP 30 mg
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk
Dabigatran Etexilate
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Class II · Moderate risk
Dabigatran Etexilate
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Class II · Moderate risk
chlorproMAZINE Hydrochloride Tablets
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Class II · Moderate risk
chlorproMAZINE Hydrochloride Tablets
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules USP
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
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