Class II · Moderate risk
Duloxetine D/R
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Mental Health Medication Recalls
Recalls of antidepressants, anti-anxiety and related psychiatric medications.
224 recalls in this category, newest first.
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 DR Capsules
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules USP
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II · Moderate risk
Xanax XR
Failed Dissolution Specifications
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II · Moderate risk
Sertraline Hydrochloride Tablets USP
Defective container - seal not adhering to bottles
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Class II · Moderate risk
Bupropion Hydrochloride Extended-Release Tablets USP
Failed Tablet/Capsule Specifications
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP deviations: N-nitroso-duloxetine impurity above the proposed 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 safety assessment 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
Fluoxetine Tablets
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Class II · Moderate risk
Fluoxetine Tablets
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake 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
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
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Class II · Moderate risk
Venlafaxine Tablets
Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Class II · Moderate risk
Duloxetine D/R
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
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