Class II · Moderate risk Ongoing
Carvedilol Tablets
Reason CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
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Class II · Moderate risk Ongoing
Carvedilol Tablets
Reason CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class II · Moderate risk Ongoing
Carvedilol Tablets
Reason CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class II · Moderate risk Ongoing
Carvedilol Tablets
Reason CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Class II · Moderate risk Ongoing
Carvedilol Tablets
Reason CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Class II · Moderate risk Ongoing
Metoprolol Tartrate Tablets
Reason CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Class II · Moderate risk Ongoing
Metoprolol Tartrate Tablets
Reason CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Class II · Moderate risk Ongoing
Enoxaparin Sodium Injection
Reason Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Class III · Low risk Ongoing
Sensodyne PRONAMEL
Reason Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
Class II · Moderate risk Ongoing
Spironolactone Tablets
Reason Presence of foreign substance: identified as aluminum.
Class II · Moderate risk Ongoing
Vial Label: 8.4% Sodium Bicarbonate Injection
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Ongoing
Vial Label: Epinephrine Injection
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection USP
Reason Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Class II · Moderate risk Ongoing
Lactated Ringer's Injection USP
Reason Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Class II · Moderate risk Ongoing
4.2% Sodium Bicarbonate Injection
Reason Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Class II · Moderate risk Ongoing
Recombinate
Reason CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk Ongoing
Xolair
Reason CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk Ongoing
Xolair
Reason CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class I · High risk Ongoing
Nad+
Reason Microbial Contamination of Sterile Products: elevated endotoxin levels
Class II · Moderate risk Ongoing
Retatrutide for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Tirzepatide
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Sermorelin Lyophilized powder for reconstitution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Epithalon for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Tesamorelin for Injection
Reason Lack of Assurance of Sterility