Recall of Acne Cream due to B.Cepacia contamination

[Necron99]

[Necron99]

November 18, 2008

FDA Announces Recall of Benzoyl Peroxide Acne Cream 10% marked as:

· DG (Dollar General Brand) Maximum Strength Acne Medicated Gel;

· Kroger (A CostCo Company, also sold there) Acne Gel 10% Benzoyl Peroxide Acne Medication;

· Equate: Medicated Acne Gel

CSI USA Inc. and FDA informed consumers and healthcare professionals of a nationwide recall of all lots of 1 ounce tubes of 10% Benzoyl Peroxide Acne Cream. The products were recalled because samples of the products were found to contain bacteria, Burkholderia cepacia, formerly known as Pseudomonas Cepacia. There may 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. Consumers should discontinue using the product and should return it to the place of purchase.

You can read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer’s recall press release at: http://www.fda.gov/oc/po/firmrecalls/csi11_08.html

Additional information can be found at the product website, http://www.acnemedrecall.com.

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