Because of microbial contamination identified as Burkholderia cepecia, DermaRite Industries, LLC is voluntarily recalling individual lots of several of its products.
According to a business statement released on Wednesday, the Burkholderia Cepacia Complex included in these goods may cause severe and potentially fatal infections.
According to the corporation, immunocompromised patients or those who care for immunocompromised people may utilize the tainted products. The product is more likely to cause local infections in healthy people with small skin lesions, but it is more likely to cause life-threatening sepsis in immunocompromised people after the infection reaches the bloodstream. As of right now, DermaRite has not heard of any negative consequences associated with this recall.
- DermaKleen is an 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, 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.
According to the notification released on Wednesday, the recalled items were shipped throughout the United States and Puerto Rico.
Through email, DermaRite has informed its distributors and customers to promptly review their inventory and dispose of any impacted items in compliance with their respective facilities’ protocols.
Customers should contact [email protected] or call Mary Goldberg at 973-569-9000 x104, Monday through Friday, from 9 a.m. to 5 p.m. EST, if they have any questions about this recall.
If customers have encountered any issues that might be connected to consuming or using this product, they should get in touch with their doctor or healthcare professional.
You can report any adverse reactions or quality issues you have with this medicine online, by regular mail, or by fax to the FDA’s MedWatch Adverse Event Reporting program.
Fill out the online report at www.fda.gov/medwatch/report.htm and submit it.Regular Mail or Fax: To obtain a reporting form, download it from www.fda.gov/MedWatch/getforms.htm, call 1-800-332-1088, fill it out, and send it back to the address on the pre-addressed form, or fax it to 1-800-FDA-0178.With the U.S. Food and Drug Administration’s knowledge, this recall is being carried out.
