DermaRite Industries, LLC is expanding the voluntary recall initiated on July 16, due to potentialmicrobial contamination identified as Burkholderia cepacia complex. Out of an abundance of caution the voluntary recall has expanded to include additional products and lots, which can be found in the table below. Please see DermaRite.com for the original recall notice.
Risk Statement: Burkholderia cepacia complex in these products may result in serious and life-threatening infections if the products are used by immunosuppressed individuals or by people attending to immunosuppressed individuals. For healthy individuals with minor skin lesions, the use of the product may result in local infections, whereas in immunocompromised individuals the infection could spread into the blood stream, potentially leading to life-threatening sepsis.
The products included in this expanded voluntary recall include:
4-N-1is a no rinse wash cream intended to temporarily protect and help relieve chafed or cracked skin
DermaCerinis a skin protectant moisturizing cream indicated to temporarily protect and help relieve dry, chapped, or cracked skin. It also helps protect skin from the drying effects of wind and cold weather.
DermaFungalis 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.
DermaKleenis an OTC healthcare antiseptic lotion soap with Vitamin E indicated for handwashing to decrease bacteria on the skin.
DermaMedis an OTC skin protectant intended to dry the oozing and weeping of poison ivy, oak, or sumac, or other skin irritations.
DermaSarrais an OTC external analgesic indicated for temporary relief of itching associated with minor skin irritations due to dry skin, insect bites, detergents, or sunburn.
Gel Rite is an OTC instant gel hand sanitizer with vitamin E used to decrease bacteria on the skin. It is recommended for repeated use.
Hand E Foam is an OTC foaming hand sanitizer with vitamin E used for handwashing to decrease bacteria on the skin. It is recommended for repeated use.
KleenFoamis 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.
Lantisepticis an OTC skin protectant indicated to temporarily protect minor cuts, scrapes and burns. It helps prevent and temporarily protect chapped or cracked skin.
PeriGiene is an OTC antiseptic cleanser indicated for use in the perineal area.
PeriGuardis an OTC 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 Dimethiconeis an OTC skin protectant indicated to help treat and prevent diaper rash, protect minor skin irritations associated with diaper rash, and helps seal out wetness.
Renew Periprotectis an OTC skin protectant indicated to help treat and prevent diaper rash, protect minor skin irritation associated with diaper rash, and helps seal out wetness.
Renew Skin Repairis an OTC Skin cream indicated to temporarily protect and help relieve chapped or cracked skin. It is beneficial for face, hands, body and legs.
UltraSureis an OTC anti-perspirant & deodorant indicated to reduce underarm wetness.
The recalled products were distributed nationwide in the United States and in Puerto Rico.
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.
Consumers with questions regarding this recall can call Sedgwick at 888-943-5190 Monday through Friday, 8:00 am – 5:00 pm EST or email dermarite5186@sedgwick.com
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product or have questions about whether the product was used in their health care facility.
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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Recalled Product Information:
Labels of affected products can be viewed here.
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SOURCE DermaRite
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