Skincare Products Recalled Because of B. cepacia Contamination

By IDSE News Staff

The FDA announced a recall of individual lots of products made by DermaRite Industries due to microbial contamination with Burkholderia cepacia. The recalled products were distributed nationwide in the United States and Puerto Rico.

B. cepacia complex in these products may result in serious and life-threatening infections, according to the FDA. “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 agency said in a statement.

To date, DermaRite has not received any reports of adverse events related to this recall. Here is a list of products affected (see more information in table below):

• DermaKleen is an over-the-counter (OTC) healthcare antiseptic lotion soap with vitamin E indicated for handwashing to decrease bacteria on the skin.
  
• DermaSarra is an OTC external analgesic indicated for temporary relief of itching associated with minor skin irritations due to dry skin, insect bites, detergents and sunburn.
  
• 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.
  
• PeriGiene is an OTC antiseptic cleanser indicated for use in the perineal area.
  

Anyone with questions regarding this recall can call Mary Goldberg at 973-569-9000 x104 or email voluntary.action@dermarite.com.

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.

Healthcare 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 or call 1-800-332-1088 to request a reporting form, which should be completed and returned to the address on the form or submitted by fax to 1-800-FDA-0178.

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