Monday, November 17, 2008

CSI, USA, Inc. issued a voluntary nationwide consumer product recall of all lots of 1 ounce (28 g) tubes of 10% Benzoyl Peroxide Acne Cream with the f

CSI, USA, Inc. issued a voluntary nationwide consumer product recall of all lots of 1 ounce (28 g) tubes of 10% Benzoyl Peroxide Acne Cream with the following names: "DG Maximum Strength Acne Medicated Gel" (sold at Dollar General): "Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication" (sold at Kroger): and "Equate: Medicated Acne Gel" (sold at Wal-Mart).Sample photos of each product can be accessed at the following weblink: http://www.fda.gov/oc/po/firmrecalls/photos/csi11_08.htmlThese products are being recalled because samples of the products were found to contain bacteria identified as "Burkholderia Cepacia," formerly known as Pseudomonas Cepacia. After conducting a thorough assessment, the company concluded that the risk of illness in healthy individuals following use of this product is very low. However, there could be an increased health risk of infections for individuals with cuts, scrapes, rashes or other compromised skin conditions: or those with weakened or suppressed immune systems. No consumer adverse health events related to this issue have been reported. No other acne medications sold by Dollar General, Kroger or Wal-Mart are affected by this recall.Consumers should discontinue using the product and may obtain a full refund by mailing the tube, or proof of purchase, to: CSI USA, Inc.170 Commerce WayGallatin, TN 37066Attn: ACNE CREAM RECALLAdditional information can be found at the product website, www.acnemedrecall.com. No action is required of local health departments at this time for any of these recalls. If any requests for assistance are received from either the FDA or USDA, the Food and Drug Safety Program will contact you. For additional information regarding these recalls, please click on the weblink below.

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