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The U.S. Food and Drug Administration (FDA) has issued a nationwide recall of a specific brand of hand soap due to the risk of sepsis. The recall was issued for hand soaps manufactured and distributed by DermaRite Industries due to microbial contamination identified as Burkholderia cepecia.
The hand soap products being recalled includes DermaKleen (an antiseptic lotion soap with Vitamin E), KleenFoam (an antimicrobial foam soap with Aloe Vera), DermaSarra (an external analgesic), and PeriGiene (an antiseptic cleanser). DermaRite Industries is voluntarily recalling individual lots of these products that were distributed across the United States and in Puerto Rico. Anyone who purchased products from the affected lots should discontinue use immediately.
“Burkholderia Cepacia Complex 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,” the company wrote in the recall announcement which was published on Saturday. “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.”
Signs and symptoms
According to the U.S. Centers for Disease Control and Prevention (CDC), Burkholderia cepacia complex, also called B. cepacia or Bcc, “can be resistant to antibiotics, making them difficult to treat.”
The CDC explains that symptoms vary, ranging from no symptoms to serious respiratory infections, especially in patients with cystic fibrosis or other chronic lung disease. Other signs of infection include fever and fatigue.
Sepsis is “a life-threatening medical emergency,” according to the CDC, and almost any infection can lead to sepsis. “Without timely treatment, sepsis can rapidly lead to tissue damage, organ failure and death,” the CDC writes.
Signs or symptoms of sepsis include clammy or sweaty skin; confusion or disorientation; extreme pain or discomfort; fever, shivering or feeling very cold; high heart rate or weak pulse; and/or shortness of breath.