Antiseptic Products Recalled Due to Contamination Risk

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Several antiseptic and antimicrobial products have been recalled by DermaRite Industries due to contamination with Burkholderia cepacia, a bacteria that can cause serious infections, especially in people with weakened immune systems.

The products, sold over the counter, may lead to local infections in healthy individuals with minor skin lesions. In immunocompromised individuals, the infection can spread into the bloodstream and cause life-threatening sepsis.

To date, there have been no reports of adverse events related to this recall.

The recalled products

The recall includes antiseptic lotion soap, analgesic for pain, foam soap for bacteria and a perineal cleanser. The products were sold across the U.S. and Puerto Rico.

The recall includes:

• DermaKleen: OTC health care antiseptic lotion soap with vitamin E
• Dermasarra: OTC external analgesic for temporary relief of itching associated with minor skin irritations
• KleenFoam: OTC antimicrobial foam soap with aloe vera
• PeriGiene: OTC antiseptic cleanser for use in the perineal area

For the full list of products, their lot numbers and expiration dates, see the recall alert.

Symptoms of a Burkholderia cepacia infection

Burkholderia cepacia infection can cause serious health problems, including pneumonia, bloodstream infections and other life-threatening conditions — especially in people with weakened immune systems.

Burkholderia cepacia complex is a group of bacteria commonly found in soil and water. People in health care settings and those with weakened immune systems or chronic lung diseases, especially cystic fibrosis, are at the highest risk of infection.

Consumers are advised to stop using the recalled products immediately. Anyone who experiences any symptoms after using these products should contact their health care provider. Contact DermaRite Industries to report any adverse events or quality issues. For more information, contact Mary Goldberg at 973-569-9000, ext. 104, or email voluntary.action@dermarite.com.