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OTC antiseptic lotion soaps, external analgesics, antimicrobial foam soaps, a...

# Major Recall Alert: OTC Antiseptic Lotion Soaps, External Analgesics, Antimicrobial Foam Soaps, and Antiseptic Cleansers Recalled Due to Contamination with Burkholderia cepacia

In a critical health alert, DermaRite Industries, LLC has issued a voluntary recall of several over-the-counter (OTC) hygiene and antiseptic products, including **DermaKleen**, **DermaSarra**, **KleenFoam**, and **PeriGiene**, due to contamination with the harmful bacteria **Burkholderia cepacia**. These products, distributed nationwide in the United States and Puerto Rico, may pose severe risks to those who use them, particularly individuals with weakened immune systems.

Keep reading for complete information about the recall, its risks, and how to ensure your safety.

## Why This Recall is Important

The **Burkholderia cepacia complex** is known to cause serious, and in some cases, life-threatening infections. Though healthy individuals with minor skin irritations might only experience localized infections from contaminated products, immunocompromised individuals face more severe risks, including systemic infections like life-threatening *sepsis*.

This recall is especially concerning because the affected products are often used in healthcare settings and by or for individuals who may already have compromised health, such as patients and elderly individuals in long-term care facilities.

The good news? To date, DermaRite Industries, LLC has received **no reports of adverse events** related to these recalled products. However, immediate action is necessary to prevent potential risks to public health.

## Details of the Recall

The recall affects the following popular OTC products manufactured by DermaRite:

- **DermaKleen**: An antiseptic lotion soap containing Vitamin E, designed for handwashing to reduce bacteria on the skin.
- **DermaSarra**: An external analgesic providing temporary relief from minor itching caused by skin irritants like dry skin, insect bites, or sunburn.
- **KleenFoam**: An antimicrobial foam soap with Aloe Vera, often used for handwashing after caring for ill individuals or medical patients.
- **PeriGiene**: An antiseptic cleanser specifically formulated for use in the perineal area.

### Key Recall Points:

- **Reason**: Contamination with *Burkholderia cepacia*.
- **Distributor**: The products were distributed across the U.S. and Puerto Rico.
- **Source**: DermaRite Industries has notified distributors and customers to remove and destroy all affected items immediately.

For more details, refer to the official FDA recall statement [here](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dermarite-industries-issues-voluntary-nationwide-recall-dermakleen-dermasarra-kleenfoam-and).

## What You Should Do

If you or your organization uses any of the affected products, take these steps immediately:

- **Check your inventory**: Identify and isolate products marked for recall.
- **Stop use immediately**: Discontinue use of any affected products to prevent potential contamination risks.
- **Destroy appropriately**: Follow facility protocols for the safe disposal of contaminated items.
- **Contact the manufacturer**: Questions regarding this recall should be directed to Mary Goldberg at **973-569-9000 x104** or via email at **voluntary.action@dermarite.com**.

### Important Note:
If you or someone you know experiences adverse effects or quality issues from using these products, report them to the FDA via the **MedWatch Adverse Event Reporting** program online, or through mail and fax.

For additional support, contact your healthcare provider to discuss any symptoms or infections that may be related to the use of these products.

## Stay Safe – Get Instant Recall Alerts

With product recalls like this happening regularly, it’s critical to stay informed to protect your health and the well-being of your family. Download our free **Product Safety Recall App** to receive instant notifications on recalls, contamination alerts, and safety issues across thousands of consumer products.

Stay proactive and in-the-know about safety concerns that may impact your household—**download the app now and stay safe.**

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For the official FDA recall notice, visit: [DermaRite Industries Issues Voluntary Nationwide Recall](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dermarite-industries-issues-voluntary-nationwide-recall-dermakleen-dermasarra-kleenfoam-and).

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