Hand soaps recalled nationwide over potential for ‘serious and life-threatening infections’

A number of soap products sold nationwide are being recalled over concerns that using them could result in “serious and life-threatening infections.”

DermaRite Industries voluntarily recalled antiseptic and antimicrobial soaps that it said could lead to infections on some open wounds and potentially “life-threatening sepsis” due to contamination with something called burkholderia cepacia complex.

“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 recall alert states.

Here’s what to know:

What is Burkholderia cepacia complex?

According to the Centers for Disease Control and Prevention, Burkholderia cepacia complex, also called B. cepacia or Bcc, is “a group of bacteria commonly found in soil and water,” and such germs can be resistant to antibiotics.

What are the symptoms?

What products were recalled?

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

• DermaKleen, an over-the-counter healthcare antiseptic lotion soap with Vitamin E

• DermaSarra, an over-the-counter external analgesic used for temporary relief of itching from minor skin irritations

• KleenFoam, an over-the-counter antimicrobial foam soap with aloe vera used 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, an over-the-counter antiseptic cleanser for “use in the perineal area.”

What to do if you have any of the recalled items?

The company said no reports of infections have been reported so far in connection with the recalled products, but it urged customers and distributors to “immediately examine available inventory and destroy all affected products in accordance with each facility’s process.”

Anyone who experiences health issues after using the product should contact their physician or healthcare provider, the recall stated.

Those with questions regarding the recall can call (973) 569-9000 x104 between 8 a.m. and 4 p.m. CT Monday through Friday or email voluntary.action@dermarite.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Full list of recalled products

Source

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