Class II · Moderate risk Ongoing
Metoclopramide Tablets
Reason Presence of foreign tablets/capsules.
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Class II · Moderate risk Ongoing
Cephalexin for Oral Suspension
Reason Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Class II · Moderate risk Ongoing
Cephalexin for Oral Suspension
Reason Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Class II · Moderate risk Ongoing
Spectrum Advanced Gel Hand Sanitizer
Reason Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Class II · Moderate risk Ongoing
Acetaminophen Tablets
Reason cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Class I · High risk Completed
Umovy Acido Hialuronico
Reason Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
Class I · High risk Completed
Unavy Acido Hialuronico
Reason Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.
Class II · Moderate risk Ongoing
Nicotinamide adenine dinucleotide
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Tirzepatide/Cyanocobalamin Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Tirzepatide/Cyanocobalamin Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Tirzepatide Injections
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Tirzepatide Injections
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Tirzepatide Injections
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide/Cyanocobalamin Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Nicotinamide adenine dinucleotide
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
LX Bioboost Plus
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
LL Bioboost Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
CJC-1295 Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Methylcobalamin Injectable
Reason Lack of Assurance of Sterility
Class III · Low risk Ongoing
Ezetimibe and Simvastatin Tablets
Reason 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.
Class II · Moderate risk Ongoing
Indomethacin Extended-Release Capsules
Reason cGMP deviations
Class II · Moderate risk Ongoing
Theophylline
Reason OOS results reported for the Dissolution (by UV) test.
Class II · Moderate risk Ongoing
BD ChloraPrep Clear
Reason Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.