‘Life-Threatening Sepsis’ Possible With These Recalled Hand Soaps

The manufacturer of several types of hand soaps sold nationwide is recalling several individual lots after testing detected a dangerous bacterial contaminant that “may result in serious and life-threatening infections,” according to the Food and Drug Administration.

New Jersey-based DermaRite Industries LLC has released a long list of products it is recalling after the discovery of Burkholderia cepacia bacterium. DermaKleen lotion soaps, PeriGiene antiseptic and KleenFoam soaps are among dozens of recalled products.

A full list of recalled products can be found on the FDA website.

“The contaminated products may be used by immunosuppressed individuals or by people attending to immunosuppressed individuals,” the company said. “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.”

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

According to the Centers for Disease Control and Prevention, Burkholderia cepacia complex can easily spread from person to person and are difficult to treat due to their antimicrobial resistance.

Symptoms vary, ranging from no symptoms to serious respiratory infections, especially in patients with cystic fibrosis or other chronic lung disease. Other symptoms may include fever and fatigue, according to the CDC.

Consumers with questions regarding this recall can call Mary Goldberg at 973-569-9000 x104 Monday through Friday, 9 a.m. – 5 p.m. EST, or by email to voluntary.action@dermarite.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using the product, the FDA said.

Adverse reactions or quality problems experienced with the use of the soaps 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:
• Regular Mail or Fax: Download the form or call 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.