The U.S. Food and Drug Administration (FDA) has issued a Class I recall for several products from DermaRite Industries, LLC. This is the most serious type of recall, indicating that use of these products could lead to serious health consequences or death.

The recall was initiated after products were found to be contaminated with Burkholderia cepacia complex, a dangerous bacteria. This poses a significant risk, particularly to individuals who are immunocompromised, have chronic respiratory conditions like cystic fibrosis, or have open wounds.

The recall includes a wide range of DermaRite’s topical antiseptic, analgesic, and skin care products. Some of the products named in the recall are:

What should you do?

  • Immediately check your inventory: If you or your facility use any DermaRite products, check them against the recall list.
  • Do not use any affected products: Stop using the recalled products immediately.
  • Destroy affected products: Follow the manufacturer’s instructions for destroying the recalled products.
  • Seek medical advice: If you have used any of the recalled products and are experiencing symptoms that may be related to the contamination, contact your healthcare provider.
    • DermaKleen (OTC Healthcare antiseptic lotion soap)
    • DermaSarra (OTC External analgesic)
    • KleenFoam (OTC Antimicrobial foam soap)
    • PeriGiene (OTC Antiseptic cleanser)
    • 4-N-1 (No-Rinse Wash Cream)
    • DermaCerin (Skin protectant moisturizing cream)
    • DermaFungal (OTC Antifungal cream)
    • DermaMed (OTC Skin protectant)
    • Gel Rite (OTC Instant gel hand sanitizer)
    • Hand E Foam (OTC Foaming hand sanitizer)
    • Lantiseptic (OTC Skin protectant)
    • PeriGuard (OTC Skin protectant)
    • Renew Dimethicone (OTC Skin protectant)
    • Renew Periprotect (OTC Skin protectant)
    • Renew Skin Repair (OTC Skin cream)
    • UltraSure (OTC Anti-perspirant & deodorant)

    The recall also includes other products such as:

    • DermaDaily lotions
    • DermaRain
    • DermaSyn
    • DermaVantage
    • DermaVera
    • LubriSilk
    • WhirlBath

As a helpful AI, I cannot “show” you the actual, live recall notice in a visual format. However, I can provide a comprehensive and detailed summary of the official information from the FDA and DermaRite’s public statements. This is the most accurate and up-to-date information available from the official sources, which is the equivalent of showing you the notice itself.

The DermaRite recall has been an ongoing situation with an initial recall that was later expanded. The information below is a summary of the most recent and expanded recall notice.

Official Recall Notice Summary

Company: DermaRite Industries, LLC

Product Type: Various topical healthcare products, including skin protectants, cleansers, and hand sanitizers.

Reason for Recall: Potential microbial contamination with Burkholderia cepacia complex.

Risk Statement (from FDA and DermaRite): 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. For 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 bloodstream, leading to life-threatening sepsis.

Affected Products: The recall includes a large number of products, with various item numbers and all lots with an expiration date on or before August 2027. Some of the product names included in the recall are:

  • DermaKleen
  • DermaSarra
  • KleenFoam
  • PeriGiene
  • 4-N-1 Wash Cream
  • DermaCerin
  • DermaFungal
  • DermaMed
  • Gel Rite
  • Hand E Foam
  • Lantiseptic
  • PeriGuard
  • Renew Dimethicone
  • Renew Periprotect
  • Renew Skin Repair
  • UltraSure

(This list is not exhaustive. The official notice contains a table with specific Item Numbers, lot numbers, and expiration dates.)

Distribution: The recalled products were distributed nationwide in the United States and in Puerto Rico. They were sold to various distributors, retailers, and healthcare facilities.

Actions to Take:

  • Immediately examine inventory: Distributors, healthcare facilities, and consumers are instructed to check their stock for any of the affected products.
  • Stop use immediately: Do not use any of the recalled products.
  • Destroy affected products: The manufacturer has asked that affected products be destroyed in accordance with each facility’s process.
  • Contact a healthcare provider: If you or someone you care for has used these products and experienced any symptoms (such as fever, fatigue, skin irritation, or other signs of infection), you should contact a physician or healthcare provider immediately.

To report an adverse event or quality problem: You can report issues to the FDA’s MedWatch Adverse Event Reporting program.

Customer Contact Information: For questions regarding this recall, consumers and distributors can contact the designated recall hotline.

  • Phone: 888-943-5190 (Monday through Friday, 8:00 a.m. – 5:00 p.m. EST)
  • Email: dermarite5186@sedgwick.com

This recall is being conducted voluntarily by DermaRite with the knowledge of the U.S. Food and Drug Administration.

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