Class II · Moderate risk
Fluoxetine Tablets
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake 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
Duloxetine Delayed-Release Capsules USP
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules USP
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk
ChlorproMAZINE Hydrochloride Tablets
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Class II · Moderate risk
chlorproMAZINE Hydrochloride Tablets
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Class II · Moderate risk
Unisom
CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Class II · Moderate risk
chlorproMAZINE Hydrochloride Tablets
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Class II · Moderate risk
Duloxetine D/R
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk
Duloxetine D/R
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets 60 mg
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets 30 mg
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk
Unisom
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Class II · Moderate risk
Carvedilol Tablets USP 25 mg
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II · Moderate risk
Carvedilol Tablets USP 12.5 mg
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II · Moderate risk
Carvedilol Tablets USP 6.25 mg
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II · Moderate risk
Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake 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 FDA recommended interim 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.
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