Allergan PLC is recalling approximately 12,573 units of Skin Medica Acne Treatment Lotion and Acne Systems because the products are subpotent, meaning they failed testing for active ingredient levels at the 12 and 24-month marks. This recall includes 4,018 individual 2 oz bottles of the Benzoyl Peroxide 2.5% lotion and 8,555 Acne System kits containing various salicylic acid and benzoyl peroxide treatments. These products were distributed nationwide across the United States. If you have these products, you should contact your healthcare provider or pharmacist for guidance regarding their effectiveness.
The drug products failed assay results, meaning they do not contain the expected amount of active ingredients required to effectively treat acne. Using a subpotent medication may result in the failure of the treatment to manage the skin condition as intended.
Drug potency issue remedy
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Sources: FDA iRES ยท Raw API Response
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