Products withdrawn from the market due to microbial pollutants in their composition
DermaRite Issues Voluntary Recall of Skin-Cleansing Products Due to Bacterial Contamination
DermaRite Industries has announced a voluntary recall of several skin-cleansing and antiseptic products due to contamination with the Burkholderia cepacia complex (BCC), a potentially harmful bacteria. The affected products include DermaKleen antiseptic lotion soap, DermaSarra analgesic, KleenFoam antimicrobial foam soap, and PeriGiene antiseptic cleanser.
These products were distributed across the United States and Puerto Rico with expiration dates ranging from July 2025 to February 2027. The recall is necessary due to the health risks associated with BCC, particularly for immunocompromised individuals. In such vulnerable populations, use of contaminated products can lead to serious complications such as bloodstream infections and sepsis, which can be life-threatening. In healthy people with minor skin lesions, infections are more likely to remain localized.
As of now, DermaRite has not received any reported adverse events linked to these products. However, the company has urged distributors and customers to immediately examine and destroy affected products. Consumers who have used the products and experience symptoms are advised to contact their healthcare provider.
If you have any questions about the recall, you can contact Mary Goldberg at 973-569-9000 x104 or email [email protected]. You can also download a reporting form from www.fda.gov/MedWatch/getforms.htm or request one by calling 1-800-332-1088. Adverse reactions or quality problems with the product can also be reported to the FDA's MedWatch Adverse Event Reporting program.
In summary, the recall addresses potential exposure to a dangerous bacterial contamination in several topical products used primarily for skin cleansing and care. The main risks involve local infection in healthy users and potentially severe systemic infections in those with weakened immune systems. It is essential for consumers to follow the instructions provided by DermaRite and seek medical attention if necessary.
The recall of DermaRite skin-cleansing products is a precautionary measure due to contamination with the Burkholderia cepacia complex, which can lead to serious medical conditions in immunocompromised individuals. This incident underscores the importance of proper health-and-wellness practices and skin-care routines to minimize risks associated with bacterial contamination.
