DermaRite recalls multiple antiseptic and skincare products over bacterial contamination risk
NEW JERSEY — DermaRite Industries, LLC, a New Jersey-base company, is voluntarily recalling certain lots of four over-the-counter antiseptic and skincare products due to microbial contamination identified as Burkholderia cepacia complex, the company announced.
The bacteria can cause serious and potentially life-threatening infections, particularly in immunocompromised individuals or those caring for them. In healthy individuals with minor skin lesions, use of contaminated products may result in local infections, while in those with weakened immune systems, the infection could spread to the bloodstream, leading to life-threatening sepsis.
The recall affects the following products, which were distributed nationwide in the U.S. and Puerto Rico:
- DermaKleen antiseptic lotion soap with Vitamin E, indicated for handwashing to decrease bacteria on the skin.
- DermaSarra external analgesic cream, indicated for temporary relief of itching associated with minor skin irritations due to dry skin, insect bites, detergents, or sunburn.
- KleenFoam antimicrobial foam soap with Aloe Vera, indicated for handwashing to decrease bacteria after changing diapers, assisting ill people, or before contact with individuals under medical care.
- PeriGiene antiseptic cleanser for use in the perineal area.
DermaRite said it has not received any reports of adverse events related to the recall. The company has notified distributors and customers via email to immediately check inventory and destroy affected products according to each facility’s process.
Consumers with questions can contact Mary Goldberg at 973-569-9000 ext. 104, Monday through Friday, 9 a.m. to 5 p.m. EST, or email voluntary.action@dermarite.com.
Customers should contact their healthcare provider if they have experienced any problems that may be related to using these products. Adverse reactions or quality problems can be reported to the U.S. Food and Drug Administration’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm or by calling 1-800-332-1088 to request a form.
This recall is being conducted with the knowledge of the FDA.
