Image courtesy FDA

DermaRite Industries, LLC is voluntarily recalling specific lots of products after tests detected Burkholderia cepacia contamination.

According to the FDA, this bacteria can cause serious, potentially life-threatening infections, especially in people with weakened immune systems or those caring for them. In healthy individuals with minor skin breaks, infections are more likely to remain localized. In immunocompromised individuals, the infection can enter the bloodstream and lead to life-threatening sepsis. No adverse events have been reported to date.

Products Affected:

• DermaKleen – Antiseptic lotion soap with Vitamin E for reducing skin bacteria.
• DermaSarra – External analgesic for temporary itch relief from skin irritations.
• KleenFoam – Antimicrobial foam soap with Aloe Vera for handwashing.
• PeriGiene – Antiseptic cleanser for the perineal area.

The products were distributed nationwide, including Puerto Rico. Distributors and customers have been instructed to examine inventory and destroy affected products per facility procedures.

Adverse reactions or quality concerns can be reported to the FDA MedWatch program:

• Online: www.fda.gov/medwatch/report.htm
• Mail/Fax: Download forms at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088. Return forms by mail to the address provided or fax to 1-800-FDA-0178.

A full list of affected products along with pictures can be found on the FDA website.