Products pulled from the market due to microbiological impurities in skin care items
In a recent development, DermaRite Industries has announced a recall of several of its antiseptic and analgesic products due to potential contamination with Burkholderia cepacia complex (BCC). This bacteria can lead to serious and potentially life-threatening infections, particularly for individuals with weakened immune systems.
The recalled products include DermaKleen Antiseptic Lotion Soap, DermaSarra External Analgesic, KleenFoam Antimicrobial Foam Soap, and PeriGiene Antiseptic Cleanser. It is advised that these products should be avoided, especially by immunocompromised individuals or their caregivers.
The potential risks associated with BCC contamination include localized skin infections in healthy individuals, severe infections such as pneumonia and bloodstream infections, and in immunocompromised individuals or those with chronic lung diseases, the risk of progressing to life-threatening sepsis. The bacteria's potential resistance to antibiotics can make infections difficult to treat.
If you have experienced any problems related to the recalled products, it is essential to contact your physician or healthcare provider immediately. For questions about the recall, you can contact Mary Goldberg at 973-569-9000 x104 or email [email protected].
A reporting form can be downloaded at www.fda.gov/MedWatch/getforms.htm or requested by calling 1-800-332-1088. The completed form can be returned by mail or submitted by fax to 1-800-FDA-0178. Alternatively, the report can be completed and submitted online at www.fda.gov/medwatch/report.htm.
DermaRite has notified its distributors and customers to destroy all affected products. Adverse reactions or quality problems with the product can also be reported to the FDA's MedWatch Adverse Event Reporting program.
To date, no adverse events have been reported from these specific recalled lots. However, consumers are urged to stop using them immediately and consult healthcare providers if symptoms appear, such as fever, fatigue, respiratory distress, or skin infections.
For more information, visit the FDA's recall announcement at www.fda.gov/Safety/Recalls/ArchiveRecalls/2022/2022-07-21-DermaRite-Industries-Inc-Recalls-Antiseptic-Analgesic-Products-Due-to-Potential-Burkholderia-cepacia-Complex-Contamination.html.
In light of the recalled products, it's crucial for those with medical conditions or compromised immune systems to avoid using DermaKleen Antiseptic Lotion Soap, DermaSarra External Analgesic, KleenFoam Antimicrobial Foam Soap, and PeriGiene Antiseptic Cleanser, as they may pose a health-and-wellness risk due to potential BCC contamination. Severe medical conditions such as skin infections, pneumonia, bloodstream infections, and even sepsis can occur if these products are used, especially for those with chronic lung diseases or weakened immune systems.
