Acne creams sold at Dollar General, Kroger or Wal-Mart have been recalled because of bacterial contamination.  According to the Food & Drug Administration (FDA), the recalled acne creams most likely do not pose a hazard to healthy people, but could be harmful to anyone with a compromised immune system.

All of the acne creams involved in this recall were manufactured by CSI, USA, Inc.  The acne cream recall involves 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). No other acne medications sold by Dollar General, Kroger or Wal-Mart are affected by this recall.

According to the FDA, the acne creams are being recalled because samples of the products were found to contain bacteria identified as “Burkholderia Cepacia,” formerly known as Pseudomonas Cepacia.  In addition to posing a risk to those with compromised immune systems, this bacteria could place individuals with cuts, scrapes, rashes or other compromised skin conditions at risk of infections.

According to the Centers for Disease Control (CDC), Burkholderia Cepacia  is the name for a group or “complex” of bacteria that can be found in soil and water.  These pathogens are often resistant to common antibiotics, and are a known cause of infection in hospitalized patients.  The effects of Burkholderia Cepacia infection in  people vary widely, ranging from no symptoms at all, to serious respiratory infections, especially in patients with Cystic Fibrosis.

Consumers should discontinue using the contaminated acne creams 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.

In the past, outbreaks of Burkholderia Cepacia have linked to contaminated mouthwash, nasal spray and medical devices.  Last December, pre-filled heparin syringes distributed by Sierra Pre-Filled, also known as AM2 PAT, of Angier, North Carolina., where linked to an outbreak of   Burkholderia Cepacia.  Around 40 people in Texas and Illinois where sickened by the contaminated Sierra Pre-Filled Syringes.

This entry was posted on Friday, November 14th, 2008 at 9:25 am and is filed under Legal News, Pharmaceuticals, Product Recalls, Recalled Drugs.