Recall of DermaRite Industries' Skin Products Due to Bacterial Contamination
Products pulled from shelves due to microbial impurity
DermaRite Industries, LLC has voluntarily recalled several of its over-the-counter (OTC) skin care products following the detection of the Burkholderia cepacia complex (BCC), a potentially harmful bacterium. This bacterium can cause serious or life-threatening infections, particularly in immunocompromised individuals.
Affected Products
The recall includes the following products:
- DermaKleen: An antiseptic lotion soap with Vitamin E, used for handwashing to reduce bacteria on the skin.
- DermaSarra: An external analgesic for temporary relief of itching associated with minor skin irritations.
- KleenFoam: An antimicrobial foam soap with aloe vera, used for handwashing after assisting ill individuals or before medical care.
- PeriGiene: An antiseptic cleanser for use in the perineal area.
Risks and Symptoms
- Immunocompromised Individuals: The use of contaminated products by immunosuppressed individuals or those caring for them can lead to infections that spread into the bloodstream, potentially causing life-threatening sepsis.
- Healthy Individuals: In healthy individuals with minor skin lesions, the infection is more likely to cause local infections.
- Symptoms: Possible symptoms of BCC infection include fever, fatigue, and respiratory issues. In severe cases, it can lead to sepsis, which is life-threatening.
Recall Details
- Distribution: The affected products were distributed nationwide in the U.S. and in Puerto Rico.
- Adverse Events: As of the latest reports, there have been no adverse events associated with the recall.
- Action Required: Customers and distributors have been notified to check their products and destroy any items mentioned in the recall.
For specific information, including lot numbers and expiration dates, it is recommended to consult the FDA's recall alert or contact DermaRite Industries directly.
Reporting Adverse Events
Adverse reactions or quality problems with the recalled product can be reported to the FDA's MedWatch Adverse Event Reporting program. Reports can be submitted online at www.fda.gov/medwatch/report.htm or by calling 1-800-332-1088. The fax number for reporting is 1-800-FDA-0178.
For queries regarding the recall, contact Mary Goldberg at 973-569-9000 x104 or email [email protected]. The reporting form can also be downloaded from www.fda.gov/MedWatch/getforms.htm.
If you have experienced problems related to the recalled product, it is advisable to consult your healthcare provider.
- The affected products, including DermaKleen, DermaSarra, KleenFoam, and PeriGiene, are skin care products that are part of the health-and-wellness sector and could potentially lead to medical-conditions due to bacterial contamination.
- Immunocompromised individuals, who are at risk due to their weakened immune systems, should be particularly cautious when using these contaminated skin care products, as they could face severe consequences like life-threatening sepsis or spread of the infection into the bloodstream.
