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TOPIC: DermaKleen, Dermasarra, Kleenfoam, and Perigiene Products by DermaRite Industries: Recall - Due to Burkholderia cepacia Contamination
AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy, Dermatology
ISSUE: DermaRite Industries is recalling individual lots of products in the table below due to microbial contamination identified as Burkholderia cepacia.
Risk Statement: Burkholderia cepacia complex (BCC) in these products may result in serious and life-threatening infections. The contaminated products may be used by immunosuppressed individuals or by people attending to immunosuppressed individuals. In healthy individuals with minor skin lesions the use of the product will more likely result in local infections, whereas in immunocompromised individuals the infection is more likely to spread into blood stream leading to life-threatening sepsis.
The recalled products were distributed nationwide in the United States and in Puerto Rico.
To date, DermaRite has not received any reports of adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND:
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DermaKleen is an OTC Healthcare antiseptic lotion soap with Vitamin E indicated for handwashing to decrease bacteria on the skin.
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DermaSarra is an OTC External analgesic indicated for temporary relief of itching associated with minor skin irritations due to dry skin, insect bites, detergents, sunburn.
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KleenFoam is an OTC Antimicrobial foam soap with aloe vera indicated for handwashing to decrease bacteria on the skin after changing diapers, after assisting ill people, or before contact with a person under medical care or treatment.
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PeriGiene is an OTC Antiseptic cleanser indicated for use in the perineal area.
RECOMMENDATIONS:
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Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
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Consumers with questions regarding this recall can call Mary Goldberg at 973-569-9000 x104 or email voluntary.action@dermarite.com.
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DermaRite has notified its distributors and customers by e-mail to immediately examine available inventory and destroy all affected products in accordance with each facility’s process.
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Health care professionals, patients and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
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Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
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