The Office of Developmental Programs (ODP) has shared this important announcement from the U. S. Food and Drug Administration (FDA).

FDA MedWatch — DermaKleen, Dermasarra, Kleenfoam, and Perigiene Products by DermaRite Industries

DermaRite Industries is recalling the below products due to microbial contamination identified as Burkholderia cepacia.

Risk Statement:

Burkholderia cepacia complex (BCC) 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.

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

To date, DermaRite has not received any reports of adverse events related to this recall.

Background:

• 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.

Recommendations:

• Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
• Consumers with questions regarding this recall can contact Mary Goldberg at 973-569-9000 x104 or via email.
• DermaRite has notified its distributors and customers by email to immediately examine available inventory and destroy all affected products in accordance with each facility’s process.

For more information about this recall and specific product number, visit the FDA’s website.