SAN ANTONIO – DermaRite is issuing a voluntary nationwide recall for certain products due to a possible microbial contamination.
The contamination, known as Burkholderia cepacia, could result in life-threatening infections, including sepsis, according to the U.S. Food and Drug Administration (FDA).
The contaminated products may have been used by immunocompromised individuals or caregivers of immunocompromised individuals, the FDA said.
While healthy adults will likely only have local infections if they use the recalled products, immunocompromised individuals are more likely to experience more severe infections, which could lead to life-threatening injuries, the FDA said.
As of this writing, there have been no reports of adverse reactions related to this recall.
The FDA listed the following products in its recall notice:
DermaKleen – This is an over-the-counter (OTC) Healthcare antiseptic lotion soap for handwashing. It contains Vitamin E, which helps decrease bacteria on the skin.
KleenFoam – This is an OTC Antimicrobial foam soap used to help disinfect after assisting ill people, changing diapers or before coming into contact with a person under treatment for medical care.
DermaSarra – This is an OTC External analgesic used for temporary relief of itching with minor skin irritations because of dry skin, sunburn, insect bites and detergents.
PeriGiene – This is an OTC Antiseptic cleanser to be used in the perineal area.
DermaRite has reached out to all known distributors and customers by email to inspect and destroy the affected products, the FDA said.
These products were sold through DermaRite’s website and on Amazon.com.
If you have questions about the recall, you can call Mary Goldberg at 973-569-9000, extension 104, Monday to Friday, 8 a.m. to 4 p.m. The FDA said you can also email voluntary.action@dermarite.com.
If you have experienced any adverse reactions related to this product, please contact your healthcare provider immediately.
Additionally, be sure to report the reaction to the FDA’s MedWatch Adverse Event Reporting program through an online form, by calling 1-800-332-1088, or by submitting a fax of the form to 1-800-FDA-0178, the FDA stated.
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