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CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Lack of Assurance of Sterility
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.
Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Presence of foreign tablets/capsules.
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Undeclared Milk Allergen