Class I - Dangerous
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Direct Rx
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class I - Dangerous
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Class I - Dangerous
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Class I - Dangerous
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
cGMP deviations
Class I - Dangerous
cGMP deviations
Class I - Dangerous
cGMP deviations
Class I - Dangerous
cGMP deviations
cGMP deviations
cGMP deviations
Class I - Dangerous
cGMP deviations
cGMP deviations
Class I - Dangerous
cGMP deviations
cGMP deviations
cGMP deviations
Class I - Dangerous
cGMP deviation: discontinue of stability support for product.
Class I - Dangerous
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Defective Container: Leaking containers.
Class I - Dangerous
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Failed impurities/degradation specifications
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Class I - Dangerous
cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally qualified for use by the manufacturing site.
Class I - Dangerous
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.