A New Jersey-based medical care and skin care products manufacturer is sharing an update after expanding a voluntary recall of multiple types of hand soap, cleanser and antiseptic products last month due to potential bacterial contamination.
In a letter dated Sept. 8 and shared on its company website, DermaRite Industries, LLC said it recognized "the impact this situation may have caused and sincerely regret any inconvenience," stating its dedication to maintaining "the highest standards of care."
"Restoring full product availability is our highest priority," the company said in part. "Importantly, we want to confirm that our wound care and nutritional products are not part of this voluntary product recall and remain available for your continued use."
"Our actions reflect our dedication to acting quickly, transparently, and responsibly, so that we can maintain the highest standards of care," the company added.
DermaRite announced the initial recall on Aug. 8. The company then issued an expansion of the recall on Aug. 27, impacting 16 products overall.
Recalled products include 4-N-1 no-rinse wash creams, DermaCerin moisturizing creams, DermaFungal antifungal creams, DermaKleen antiseptic lotion soaps, DermaMed skin protectants, DermaSarra external analgesics, Gel Rite instant gel hand sanitizers and Hand E Foam foaming hand sanitizers.
Additional products impacted by the recall include KleenFoam antimicrobial foam soaps, Lantiseptic skin protectants, PeriGiene antiseptic cleansers, PeriGuard skin protectants, Renew Dimethicone skin protectants, Renew Periprotect skin protectants, Renew Skin Repair skin creams, and UltraSure anti-perspirant and deodorants.
All of the recalled items were distributed in the U.S. and Puerto Rico.
Impacted products have expiration dates ranging from July 2025 to August 2027. A full list of affected lot and reorder numbers can be found here.
DermaRite said in its earlier announcements that the impacted products are potentially contaminated with Burkholderia cepacia, a type of bacteria that can cause serious or life-threatening infections.
"The contaminated products may be used by immunosuppressed individuals or by people attending to immunosuppressed individuals," DermaRite stated. "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 Centers for Disease Control and Prevention states that Burkholderia cepacia, also referred to as B. cepacia or Bcc, often spreads through soil and water sources, in addition to contaminated surfaces and products and through person-to-person contact.
When someone is infected with the bacteria, they may not exhibit any symptoms. If they do show symptoms, they may experience respiratory issues or a fever or fatigue.
People who are immunocompromised or those with chronic lung conditions including cystic fibrosis are at higher risk of becoming infected with B. cepacia, according to the CDC.
The bacteria can also be resistant to antibiotics, making infections difficult to treat, the CDC states.
DermaRite said it has already notified its distributors and customers via e-mail "to immediately examine available inventory" and to destroy any recalled products "in accordance with each facility's process."
The company has not said whether it has received any reports of adverse reactions in connection with the recall. Anyone experiencing symptoms after product use should consult with their health care provider and report adverse reactions to the FDA's MedWatch Adverse Event Reporting program, it added.
Customers with questions or those in need of further information on the recall can contact DermaRite representative Sedgwick at 888-943-5190 Monday through Friday, 8:00 am – 5:00 pm EST or email dermarite5186@sedgwick.com.
ABC News has reached out to DermaRite Industries for comment.
Editor's note: This article has been updated to include a statement from DermaRite, as well as the most recent information on the recall and expansion.
