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Lack of Assurance of Sterility.
Defective Container
Failed Dissolution Specifications
Subpotent Drug
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Lack of Assurance of Sterility
CGMP Deviations: Potential presence of metal particulate matter