Approximately 51.5 million tablets of various pain relief medications, including brands like Advance Formula, PainAway II, and Vica-Cet, are being recalled because they failed stability testing. These over-the-counter medications, which contain Acetaminophen, Aspirin, and Caffeine, were found to have levels of a breakdown product called Salicylic Acid that exceeded safety limits. Consumers should stop using these products and contact a healthcare professional, as the chemical imbalance may affect the safety or effectiveness of the drug.
The tablets contain 'out-of-specification' levels of Salicylic Acid, a compound related to Aspirin that can increase when the medication becomes unstable over time. Excessive levels of this compound can lead to increased toxicity or reduced effectiveness of the pain reliever.
Drug product stability failure remedy
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Sources: FDA iRES · Raw API Response
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