DermaRite Industries, LLC is voluntarily recalling individual lots of products in the table below due to microbial contamination identified as Burkholderia cepecia.

Risk Statement: Burkholderia Cepacia Complex in these products may result in serious and life-threatening infections. The contaminated products may be used by immunosuppressed individuals or by people attending to immunosuppressed individuals. In healthy individuals with minor skin lesions the use of the product will more likely result in local infections, whereas in immunocompromised individuals the infection is more likely to spread into blood stream leading to life-threatening sepsis. To date, DermaRite has not received any reports of adverse events related to this recall.

DermaKleen is an OTC Healthcare antiseptic lotion soap with Vitamin E indicated for handwashing to decrease bacteria on the skin.

DermaSarra is an OTC External analgesic indicated for temporary relief of itching associated with minor skin irritations due to: dry skin, insect bites, detergents, sunburn.

KleenFoam is an OTC Antimicrobial foam soap with Aloe Vera indicated for handwashing to decrease bacteria on the skin after changing diapers, after assisting ill people, or before contact with a person under medical care or treatment.

PeriGiene is an OTC Antiseptic cleanser indicated for use in the perineal area.

The recalled products were distributed nationwide in the United States and in Puerto Rico.   back...