DermaRite Industries has voluntarily recalled specific lots of its products nationwide due to contamination with Burkholderia cepacia, a bacterium that can cause serious infections in immunocompromised individuals.
The products include DermaKleen, Dermasarra, Kleenfoam, and Perigiene items.
Newsweek contacted DermaRite Industries for comment via online form on Sunday.
Why It Matters
Burkholderia cepacia is a group of bacteria commonly found in soil and water. While it typically poses little risk to healthy individuals, it can lead to life-threatening infections, including sepsis, in those with weakened immune systems. The affected products were distributed across the United States and Puerto Rico.
What To Know
The products are commonly used in health care settings for handwashing and skin care. The recalled products, as per the company recall notice, are:
A full list of recalled products and product labels is also provided on the Food and Drug Administration’s website here.
What People Are Saying
Recall notice risk statement on the DermaRite website: “Burkholderia cepacia complex 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 [the] blood stream leading to life-threatening sepsis. To date, DermaRite has not received any reports of adverse events related to this recall.”
What Happens Next
Individuals using these products, especially those with compromised immune systems, should discontinue use immediately.
The company advises that consumers should contact their physician or health care provider if they have experienced any problems that may be related to using this product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA‘s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
- Complete and submit the report online: www.fda.gov/medwatch/report.htm
- Mail or fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Consumers with questions regarding this recall can call DermaRite on 973-569-9000 x104 Monday through Friday, 9 a.m.—5 p.m. ET, email [email protected], or visit the official website.
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