FDA-Drug2012-11-14Class III
AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottle, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0101-00, UPC 7 88521 12020 8.
Valeant Pharmaceuticals
Hazard
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Sold states
Nationwide
Affected count
145,650 bottles
Manufactured in
700 Rte 206 North, N/A, Bridgewater, NJ, United States
Products
AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottle, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0101-00, UPC 7 88521 12020 8.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-044-2013Don't want to check this manually?
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