Products pulled from shelves due to microbial growth concerns
In a recent development, DermaRite Industries has issued a recall for certain over-the-counter skin products due to unspecified issues. The affected products include DermaKleen antiseptic lotion soap with vitamin E, KleenFoam antibacterial foam soap with aloe vera, DermaSarra external analgesic, and PeriGiene antiseptic cleanser. These products were distributed across the United States and Puerto Rico [1][2][3][4][5].
The U.S. Food and Drug Administration (FDA) is urging consumers not to use these products until more information is available. Consumers who have these products are advised to stop using them immediately and follow the recall instructions provided by DermaRite Industries.
The recall is particularly concerning for immunocompromised individuals, as infection from the contaminant in question, Burkholderia cepacia complex, can spread from local sites into the bloodstream, leading to life-threatening sepsis and serious systemic infections. Symptoms can range from fever and fatigue to serious respiratory infections and bloodstream infections [1][3][5].
In healthy individuals, the risk is generally limited to local skin infections at minor skin lesion sites where the contaminated product is applied. However, the potential for widespread and dangerous illness in vulnerable populations underscores the importance of this recall.
DermaRite Industries has notified distributors and customers to examine and destroy affected products. Consumers experiencing problems related to the product should contact their physician or healthcare provider. For recall-related questions, consumers can contact Mary Goldberg at 973-569-9000 x104 or email [email protected].
Adverse reactions or quality problems with the product can be reported to the FDA's MedWatch Adverse Event Reporting program. Consumers can download a reporting form from www.fda.gov/MedWatch/getforms.htm or request one by calling 1-800-332-1088. The FDA's MedWatch report can also be submitted online at www.fda.gov/medwatch/report.htm.
It is crucial for everyone, especially those who are immunosuppressed or caring for immunosuppressed individuals, to heed this recall and take necessary precautions to protect their health.
[1] FDA Recall Notification: DermaRite Industries, Inc. Recalls Certain Skin Care Products Due to Potential Contamination [2] DermaRite Industries Issues Voluntary Recall of Certain Skin Care Products [3] DermaRite Skin Care Products Recalled Due to Potential Contamination [4] U.S. FDA Warns of Recall of DermaRite Skin Care Products [5] DermaRite Skin Care Products Recall: What You Need to Know
The recall of DermaRite Industries' skin care products raises concerns for those with medical conditions, as the contaminant Burkholderia cepacia complex can lead to serious health issues. It's crucial for consumers, especially those who are immunocompromised, to follow the instructions provided by DermaRite and report any problems to the FDA's MedWatch Adverse Event Reporting program.
