FDA (Drugs) recall action 63488
The FDA (Drugs) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.
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.
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.
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Valeant Pharmaceuticals is recalling AcneFree 3-in-1 Acne Night Repair Foam because the salicylic acid ingredient is subpotent and the label is inaccurate.
Valeant Pharmaceuticals is recalling AcneFree 24 Hour Severe Acne Clearing System cartons because the benzoyl peroxide ingredient is subpotent and the product is mislabeled.
Valeant Pharmaceuticals is recalling 619,029 tubes of AcneFree Original Strength Terminator because the product is subpotent and mislabeled.
Valeant Pharmaceuticals is recalling AcneFree Acne Pore Cleanser because the benzoyl peroxide ingredient is subpotent and the label contains errors regarding inactive ingredients.
Valeant Pharmaceuticals is recalling AcneFree Severe Maximum Strength Acne Pore Cleanser because the benzoyl peroxide ingredient is subpotent and the label contains errors.
Valeant Pharmaceuticals is recalling AcneFree Oil-Free Acne Cleanser because the benzoyl peroxide ingredient is subpotent and the label contains errors regarding inactive ingredients.
Valeant Pharmaceuticals is recalling AcneFree Acne Astringent Toner Pads because the salicylic acid ingredient was found to be subpotent.
Valeant Pharmaceuticals is recalling AcneFree 24 Hour Clearing System cartons because the benzoyl peroxide active ingredient is subpotent and the labels contain errors regarding inactive ingredients.