FDA-Drug2012-11-14Class III

AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13548 6.

Valeant Pharmaceuticals
Hazard

Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.

Sold states
Nationwide
Affected count
81,319 canisters
Manufactured in
700 Rte 206 North, N/A, Bridgewater, NJ, United States
Products
AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13548 6.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-047-2013

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