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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

CSI USA, Inc. Issues Voluntary National Recall of Topical Acne Cream

 

Contact:
George J. Phillips, Esq.
(615) 822-8822

 

FOR IMMEDIATE RELEASE -- GALLATIN, TN, November 13, 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 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).

These 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 Way
Gallatin, TN 37066
Attn: ACNE CREAM RECALL

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

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