Cross Contamination with Other Products
Glenmark Pharmaceuticals Inc., USA
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Failed Impurities/Degradation Specifications
CGMP Deviations: Market complaints received for gritty texture (grainy)
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
OOS results reported for the Dissolution (by UV) test.
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class I - Dangerous
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Class I - Dangerous
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class I - Dangerous
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class I - Dangerous
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class I - Dangerous
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class I - Dangerous
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class I - Dangerous
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class I - Dangerous
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class I - Dangerous
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Class I - Dangerous
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Class I - Dangerous
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Class I - Dangerous
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Defective Container: Firm received complaints of broken tube at the seal.
Defective Delivery System: The dip tube is clogged causing the spray not to work.
Subpotent Drug
Failed Dissolution Specifications: below specification results
CGMP Deviations
CGMP Deviations
Failed Dissolution Specifications
Failed Dissolution Specifications
CGMP Deviations
Failed Dissolution Specifications: results below specifications
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class I - Dangerous
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class I - Dangerous
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Failed Dissolution Specifications
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).