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Reason CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug…
Reason CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Reason CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Reason CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Reason CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Reason Chemical Contamination: Presence of benzene
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Reason Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Reason Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Reason Presence of Foreign Tablets/Capsules.
Reason Failed Dissolution Specifications - low dissolution results
Reason Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Reason Chemical Contamination: Presence of benzene.
Reason Presence of foreign tablets/capsules
Reason Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
Reason Presence of Particulate Matter
Reason Lack of Assurance of Sterility: due to a quality control process deviation
Reason Subpotent Drug
Reason Subpotent Drug
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.