Soap, lotion, and antiseptic cleanser produced by DermaRite have been recalled due to potential bacterial contamination concerns
The U.S. Food and Drug Administration (FDA) has announced a warning about potential contamination of certain skincare products, leading to a nationwide recall by DermaRite, a manufacturer of skincare, wound care, and infection control products.
The recall affects four brands: DermaKleen antiseptic lotion soap, DermaSarra pain-relieving cream, KleenFoam antimicrobial foam soap, and PeriGiene antiseptic perineal cleanser. These products were distributed across the United States and Puerto Rico, and are used primarily in healthcare settings.
The affected products can be identified by specific reorder numbers and lot codes, which have been published by the FDA. It is crucial to note that the recall does not affect all products manufactured by DermaRite.
The Burkholderia cepacia bacteria, commonly found in soil and water, is the source of the potential contamination. This bacteria can cause serious health issues such as pneumonia, bloodstream infections, and life-threatening sepsis, particularly in people who are immunocompromised or have chronic lung diseases like cystic fibrosis.
In vulnerable patients, the bacteria may spread to the bloodstream, potentially causing life-threatening sepsis. Healthy individuals face minimal risk from the bacteria, but use of contaminated products on open skin lesions could result in localized infections. The recall is particularly significant for immunocompromised patients, as infections pose a heightened danger to them.
Symptoms in affected individuals may include fever, fatigue, respiratory problems, localized skin infections, and in severe cases, bloodstream infections that may progress to sepsis, especially in immunocompromised patients. The risks for immunocompromised patients are higher, with a greater likelihood of infection spreading from localized skin lesions to the bloodstream, increased severity, and difficulty in treatment due to antibiotic resistance exhibited by B. cepacia.
DermaRite has not received any reports of adverse events linked to the recalled lots. Consumers with recalled items are advised to stop using them immediately and contact their healthcare provider if they have concerns. Adverse reactions can also be reported to the FDA's MedWatch Adverse Event Reporting program.
DermaRite has advised distributors and healthcare customers to review their inventories and destroy affected products following facility procedures. The contamination is with Burkholderia cepacia bacteria.
Questions about the recall can be directed to [email protected]. It is essential for everyone, especially healthcare providers and immunocompromised individuals, to be vigilant and take necessary precautions to avoid potential exposure to this bacteria.
- The contamination of DermaRite's skincare products, particularly the DermaKleen antiseptic lotion soap and PeriGiene antiseptic perineal cleanser, can potentially lead to medical-conditions such as pneumonia, bloodstream infections, and sepsis, especially for immunocompromised patients or those with neurological-disorders like cystic fibrosis.
- In light of the FDA's nationwide recall of DermaRite's healthcare products, people, especially healthcare providers and the immunocompromised, are urged to prioritize health-and-wellness and skin-care practices, emphasizing the importance of vigilance and adherence to proper uses of skincare products to avoid potential exposure to the Burkholderia cepacia bacteria.
