Nationwide recall alert: Soap products may cause sepsis, life-threatening infections
DermaRite Industries initiated the recall after discovering the products may be contaminated with Burkholderia Cepacia. This bacteria can cause local infections in healthy people with cuts, but it poses a serious risk to those with weakened immune systems, potentially leading to life-threatening sepsis if it enters the bloodstream.
Exposure to Burkholderia Cepacia can lead to various symptoms from no symptoms at all to serious respiratory infections especially in patients with cystic fibrosis or other chronic lung disease, according to the Center for Disease Control (CDC). Other symptoms may include fever and fatigue.
'DermaRite has notified its distributors and customers by e-mail to immediately examine available inventory and destroy all affected products in accordance with each facility's process,' the statement reads. 'Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.'
The products being recalled are:
DermaKleen, an over-the-counter healthcare antiseptic lotion soap with vitamin E
DermaSarra, an over-the-counter gel used for temporary relief of itching associated with minor skin irritations due to dry skin, insect bites, detergents, sunburn
KleenFoam, an over-the-counter foam soap with Aloe Vera used for handwashing
PeriGiene, an over-the-counter antiseptic cleaner used for the perineal area
The recalled products were distributed across the United States and in Puerto Rico, the FDA said.
DermaRite had not received any reports of adverse events related to this recall.
However, customers can report reactions or quality issues related to the products to FDA's MedWatch Adverse Event Reporting program either online or by mail or fax by downloading this form.
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