FDA (Drugs) recall action 63488

Valeant Pharmaceuticals recalled 8 products on 2012-11-14

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.

Products: 8
Announced: 2012-11-14
Critical: 0
Units: 2,618,539

Why these products were recalled

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.

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.

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.

1–8 of 8

ModerateFDA (Drugs)··2012-11-14
Valeant Recalls Subpotent AcneFree 24 Hour Severe Acne Clearing System
Valeant Pharmaceuticals is recalling AcneFree 24 Hour Severe Acne Clearing System cartons because the benzoyl peroxide ingredient is subpotent and the product is mislabeled.
Product
AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 mL) bottle Antibacterial Cleansing Wash (benzoyl peroxide 2.5% w/v) AFSV-0101-00, 1-count 4 fl oz (118 mL) bottle Corrective Toner AFSV-0201-01, 1-count 2 fl oz (59 mL) bottle Maximum Strength Repair…
Category
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0 states
LowFDA (Drugs)··2012-11-14
Valeant Recalls AcneFree Toner Pads Due to Low Salicylic Acid Content
Valeant Pharmaceuticals is recalling AcneFree Acne Astringent Toner Pads because the salicylic acid ingredient was found to be subpotent.
Product
AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v); 60-count pads per jar, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13551 6.
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0 states
LowFDA (Drugs)··2012-11-14
Valeant Recalls Subpotent AcneFree 24 Hour Clearing System
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.
Product
AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free Purifying Cleanser (benzoyl peroxide 2.5% w/v) AFCS-0101-00, 1-count 4 fl oz (118 mL) Renewing Toner AFCS-0201-01, and 1-count 2 fl oz (59 mL) Repair Lotion (benzoyl peroxide 3.7% w/v) AFCS-0301-00 per…
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0 states
ModerateFDA (Drugs)··2012-11-14
Valeant Recalls Subpotent AcneFree Oil-Free Acne Cleanser
Valeant Pharmaceuticals is recalling AcneFree Oil-Free Acne Cleanser because the benzoyl peroxide ingredient is subpotent and the label contains errors regarding inactive ingredients.
Product
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.
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0 states
LowFDA (Drugs)··2012-11-14
FDA Recalls Subpotent AcneFree Benzoyl Peroxide Cleanser
Valeant Pharmaceuticals is recalling AcneFree Severe Maximum Strength Acne Pore Cleanser because the benzoyl peroxide ingredient is subpotent and the label contains errors.
Product
AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13350 9.
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0 states
ModerateFDA (Drugs)··2012-11-14
Valeant Recalls Subpotent AcneFree Benzoyl Peroxide Tubes Nationwide
Valeant Pharmaceuticals is recalling 619,029 tubes of AcneFree Original Strength Terminator because the product is subpotent and mislabeled.
Product
AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g) tube, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0402, UPC 7 88521 12030 7.
Category
Distribution
0 states
ModerateFDA (Drugs)··2012-11-14
Valeant Recalls Subpotent AcneFree Acne Pore Cleanser
Valeant Pharmaceuticals is recalling AcneFree Acne Pore Cleanser because the benzoyl peroxide ingredient is subpotent and the label contains errors regarding inactive ingredients.
Product
AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13546 2.
Category
Distribution
0 states
LowFDA (Drugs)··2012-11-14
Valeant Recalls Subpotent AcneFree 3-in-1 Acne Night Repair Foam
Valeant Pharmaceuticals is recalling AcneFree 3-in-1 Acne Night Repair Foam because the salicylic acid ingredient is subpotent and the label is inaccurate.
Product
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.
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0 states