A massive hand soap recall that impacted several products sold nationwide has been expanded to include more items, including hand sanitizer, shampoo, lotions and deodorant, over concerns that using them could result in “serious and life-threatening infections” like sepsis.
The original recall was first issued in July and included four products from DermaRite Industries, LLC. The number of recalled products has now expanded to more than 30 products.
The company had voluntarily recalled a set of soaps it said could lead to infections on some open wounds and potentially “life-threatening sepsis” due to contamination with a group of bacteria called burkholderia cepacia complex.
Here’s what to know:
What products were originally recalled?
The recalled products were distributed nationwide in the United States and in Puerto Rico and include:
- DermaKleen, an over-the-counter healthcare antiseptic lotion soap with Vitamin E.
- DermaSarra, an over-the-counter external analgesic used for temporary relief of itching from minor skin irritations.
- KleenFoam, an over-the-counter antimicrobial foam soap with aloe vera used 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, an over-the-counter antiseptic cleanser for “use in the perineal area.”
Which products have been added to the recall?
- 3-N-1 is a thick foaming, rinse-free, body wash, shampoo, and perineal cleanser.
- 4-N-1 is a no rinse wash cream intended to temporarily protect and help relieve chafed or cracked skin.
- Clean-N-Free is a rinse-free, body wash, shampoo, and perineal cleanser that cleans without water.
- DermaCerin is a skin protectant moisturizing cream indicated to temporarily protect and help relieve dry, chapped, or cracked skin.
- DemaDaily is a moisturizing lotion that soothes dry, sensitive skin.
- DermaFungal is an OTC antifungal cream intended for the treatment and prevention of most athlete’s foot, jock itch, and ringworm. It relieves itching, scaling, cracking, and discomfort associated with these conditions.
- DemaKlenz is a wound cleanser.
- DermaMed is an over-the-counter skin protectant intended to dry the oozing and weeping of poison ivy, oak, or sumac, or other skin irritations.
- DermaRain is a bodywash and shampoo that is pH balanced and dye free.
- DermaSyn is a hydrogel wound dressing that provides and helps maintain a moist wound environment, facilitating autolytic debridement.
- DermaVantage is a moisturizing lotion.
- DermaVera is a full body cleanser for skin and hair. Moisturizes with shea butter.
- Gel Rite is an over-the-counter instant gel hand sanitizer.
- Hand E Foam is an over-the-counter foaming hand sanitizer with vitamin E used for handwashing.
- Lantiseptic is an over-the-counter skin protectant indicated to temporarily protect minor cuts, scrapes and burns.
- LubriSilk is a lotion that can be used on hands, face, legs, elbows and heels.
- PeriFresh is a cleanser spray designed for incontinence use.
- PeriGuard is an over-the-counter skin protectant indicated to help relieve and prevent rashes and irritation due to wetness from incontinence. It also protects chafed skin due to irritation and helps seal out wetness.
- Renew Hair and Body Wash is formulated to nourish and clean from head to toe.
- Renew Dimethicone is an over-the-counter skin protectant indicated to help treat and prevent diaper rash, protect minor skin irritations associated with diaper rash, and helps seal out wetness.
- Renew Full Body Wash & Shampoo is a bodywash & shampoo, suitable for hands, body, hair, and perineal care.
- Renew Periprotect is an over-the-counter skin protectant indicated to help treat and prevent diaper rash, protect minor skin irritation associated with diaper rash, and seal out wetness.
- Renew Skin Repair is an over-the-counter skin cream indicated to temporarily protect and help relieve chapped or cracked skin.
- San-E-Foam is a foaming hand sanitizer with vitamin E use for handwashing.
- TotalBath is a head-to-toe bodywash and shampoo.
- TotalFoam is a bodywash & shampoo for hands, body, hair, and perineal care.
- UltraSure is an over-the-counter anti-perspirant & deodorant indicated to reduce underarm wetness.
- WhirlBath is a head-to-toe bodywash and shampoo, formulated for whirlpool and tub use.
What is Burkholderia cepacia complex?
According to the Centers for Disease Control and Prevention, Burkholderia cepacia complex, also called B. cepacia or Bcc, is “a group of bacteria commonly found in soil and water,” and such germs can be resistant to antibiotics.
What are the symptoms?
Symptoms of infection can vary, “ranging from no symptoms to serious respiratory infections, especially in patients with cystic fibrosis or other chronic lung disease,” according to the CDC. Other symptoms may include things like fever or fatigue, the agency notes.
What to do if you have any of the recalled items?
The company said no reports of infections have been reported so far in connection with the recalled products, but it urged customers and distributors to “immediately examine available inventory and destroy all affected products in accordance with each facility’s process.”
Anyone who experiences health issues after using the product should contact their physician or healthcare provider, the recall stated.
Those with questions regarding the recall can call (973) 569-9000 x104 between 8 a.m. and 4 p.m. CT Monday through Friday or email voluntary.action@dermarite.com.
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
- Regular 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
Full list of recalled products
