Class II · Moderate risk Terminated
Chlorpheniramine Maleate 4 mg tablets
Reason Superpotent Drug: Stability failure for assay at 6 months test time-point.
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Class II · Moderate risk Ongoing
Sunitinib Malate Capsules
Reason Labeling: Label Mix-Up
Class II · Moderate risk Ongoing
Sunitinib Malate Capsules
Reason Labeling: Label Mix-Up
Class II · Moderate risk Ongoing
Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution
Reason Subpotent Drug
Class II · Moderate risk Ongoing
OneLAX Docusate Sodium Liquid
Reason CGMP Deviations
Class III · Low risk Terminated
Triamcinolone Acetonide Cream USP
Reason Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
Class II · Moderate risk Ongoing
Cinacalcet Tablets
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk Ongoing
Cinacalcet Tablets
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk Ongoing
Cinacalcet Tablets 30 mg
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk Completed
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Cinacalcet Tablets
Reason CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Cinacalcet Tablets
Reason CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Cinacalcet Tablets
Reason CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Liceout
Reason CGMP violations.
Class II · Moderate risk Ongoing
Liceout
Reason CGMP violations.
Class II · Moderate risk Ongoing
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas
Reason Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Class II · Moderate risk Terminated
Cisplatin Injection
Reason Failed Impurities/Degradation Specifications.
Class I · High risk Terminated
Ascorbic Acid Inj. Solution
Reason Presence of Particulate Matter: Presence of glass particulates.
Class III · Low risk Ongoing
Ciclopirox Gel 0.77%
Reason Defective Container: Firm received complaints of broken tube at the seal.
Class III · Low risk Ongoing
Kids' Cough and Chest Congestion
Reason Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Class III · Low risk Ongoing
Adult Cough and Chest Congestion
Reason Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Class II · Moderate risk Terminated
Thiamine HCl 0.9% Sodium Chloride Injection USP
Reason cGMP violations
Class II · Moderate risk Terminated
EPINEPHrine 0.9% Sodium Chloride Injection USP
Reason cGMP violations
Class II · Moderate risk Terminated
Oxytocin 0.9% Sodium Chloride Injection USP
Reason cGMP violations
Class II · Moderate risk Terminated
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP
Reason cGMP violations