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U.S. Department of Health and Human Services

Enforcement Report - Week of November 14, 2012

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Event Detail

Event ID 63488
Product Type Drugs
Status Ongoing
Recalling Firm Valeant Pharmaceuticals
City Bridgewater
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-15
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13550 9 Class III 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. 10,434 canisters D-048-2013
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. All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13548 6 Class III 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. 81,319 canisters D-047-2013
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. All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13551 6 Class III Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient. 71,369 jars D-046-2013
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. All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12020 8 Class III 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. 145,650 bottles D-044-2013
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 Lotion (benzoyl peroxide 10% w/v) AFCS-0303-00, and 1-count 1 oz (28 g) bottle AFSV-0305-03, Retinol Renewal Complex per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12900 3. All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12900 3 Class III 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. 477,107 cartons D-043-2013
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 carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12008 6. All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12008 6 Class III 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. 1,097,846 cartons D-042-2013
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. All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12030 7 Class III 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. 619,029 tubes D-045-2013
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. All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13546 2 Class III 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. 115,785 canisters D-049-2013
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