In a significant public health alert, DermaRite Industries has issued a voluntary nationwide recall of several antiseptic and antimicrobial hand soap products due to potential contamination with Burkholderia cepacia complex (Bcc), a group of bacteria that can cause serious and potentially life-threatening infections. The recall, affecting products distributed across the United States and Puerto Rico, has raised concerns among consumers, healthcare providers, and distributors. This article provides a comprehensive overview of the recall, including the affected products, health risks, what to do if you own these items, and how to stay safe.
Why Were These Soaps Recalled?
DermaRite Industries initiated the recall after discovering that certain batches of their antiseptic and antimicrobial soaps may be contaminated with Burkholderia cepacia complex. According to the company’s recall notice, these bacteria can pose a significant health risk, particularly for individuals with compromised immune systems or open wounds. While healthy individuals with minor skin lesions may experience localized infections, immunocompromised individuals are at a higher risk of developing severe infections, including life-threatening sepsis, a condition where the infection spreads to the bloodstream.
The recall was announced to prevent potential health complications and ensure consumer safety. As of the recall announcement, no infections linked to the contaminated products have been reported. However, the company is urging consumers and distributors to take immediate action to identify and destroy affected products.
What is Burkholderia cepacia Complex?
Burkholderia cepacia complex (Bcc) is a group of bacteria commonly found in soil and water. These bacteria are known for their resistance to many antibiotics, making infections difficult to treat. According to the Centers for Disease Control and Prevention (CDC), Bcc infections can range from asymptomatic to severe, particularly in individuals with underlying health conditions such as cystic fibrosis or chronic lung diseases.
Symptoms of Bcc Infections
The symptoms of a Bcc infection can vary depending on the individual’s health status and the severity of the infection. Common symptoms include:
Fever: A rise in body temperature may indicate an infection.
Fatigue: Feeling unusually tired or weak.
Respiratory Issues: Particularly in individuals with cystic fibrosis or chronic lung conditions, Bcc can cause serious respiratory infections, leading to symptoms like coughing, shortness of breath, or chest pain.
Localized Skin Infections: Redness, swelling, or pain at the site of a minor cut or wound.
Sepsis Symptoms: In severe cases, symptoms of sepsis may include rapid heart rate, confusion, low blood pressure, and organ dysfunction.
If you suspect you may have an infection after using one of the recalled products, it’s critical to contact a healthcare provider immediately.
Which Products Are Affected?
The recall includes several DermaRite products marketed as over-the-counter antiseptic and antimicrobial soaps or cleansers. These products were distributed nationwide in the United States and Puerto Rico, primarily to healthcare facilities, distributors, and retailers. Below is a detailed list of the recalled products:
1. DermaKleen
Description: An over-the-counter healthcare antiseptic lotion soap containing Vitamin E, used for general handwashing.
Packaging: Available in 800ml and 1000ml bag-in-box formats.
Reorder Numbers: 0090BB (800ml, 12/case), 0092BB (1000ml, 10/case).
Lot Numbers and Expiration Dates:
30550A, 30670A, 30682A, 40025A, 40375A, 40427A, 40436A, 50068A (800ml, expiring between July 2025 and January 2027).
30586A, 30586B, 30626A, 30628A, 30657A, 30741A, 30871A, 40002A, 40012A, 40301A, 40789A, 50068B, 50144A, 50149A (1000ml, expiring between July 2025 and February 2027).
2. DermaSarra
Description: An over-the-counter external analgesic used for temporary relief of itching caused by minor skin irritations.
Packaging: 7.5oz bottles, 24/case.
Reorder Number: 00188.
Lot Number and Expiration Date: 40187.2 (expiring February 2026).
3. KleenFoam
Description: An over-the-counter antimicrobial foam soap with aloe vera, designed to reduce bacteria on the skin during handwashing, particularly in healthcare settings or after activities like diaper changes.
Packaging: 1000ml bottles, 6/case.
Reorder Number: 0093F.
Lot Numbers and Expiration Dates: 30705A, 30771A, 30920A, 40016A, 40303A, 40428A, 40505A, 41053A, 41053B, 41053C, 50017A (expiring between August 2025 and January 2027).
4. PeriGiene
Description: An over-the-counter antiseptic cleanser used in the perineal area for personal hygiene.
Packaging: 7.5oz bottles, 48/case.
Reorder Number: 00198.
Lot Numbers and Expiration Dates: 31013A, 40345A, 40355A, 40571A, 40580A, 40587A, 40591A, 40870.1, 40877.1, 41093A, 50072A, 50079A (expiring between November 2025 and January 2027).
Consumers can identify affected products by checking the reorder number, lot number, and expiration date printed on the packaging.
What Should You Do If You Have These Products?
If you have any of the recalled products, DermaRite Industries recommends the following steps:
Check Your Inventory: Examine your stock of hand soaps and cleansers to identify any products matching the reorder numbers, lot numbers, and expiration dates listed above.
Destroy Affected Products: Safely dispose of the recalled items in accordance with your facility’s or household’s waste disposal protocols. Do not use these products, as they may pose a health risk.
Contact a Healthcare Provider: If you’ve used any of the recalled products and are experiencing symptoms such as fever, fatigue, or skin irritation, consult a physician or healthcare provider immediately.
Report Adverse Reactions: If you experience any health issues or quality problems related to these products, report them to the FDA’s MedWatch Adverse Event Reporting program. You can submit reports online, by mail, or by fax.
Reach Out to DermaRite: For questions about the recall, contact DermaRite Industries at (973) 569-9000 x104, Monday through Friday, 8 a.m. to 4 p.m. CT, or email voluntary.action@dermarite.com.
Health Risks and Vulnerable Populations
While Burkholderia cepacia complex infections are generally rare, they can be particularly dangerous for certain groups:
Immunocompromised Individuals: People with weakened immune systems, such as those undergoing chemotherapy, living with HIV/AIDS, or taking immunosuppressive medications, are at higher risk of severe infections, including sepsis.
Individuals with Chronic Lung Conditions: Those with cystic fibrosis or chronic obstructive pulmonary disease (COPD) are especially vulnerable to respiratory infections caused by Bcc.
People with Open Wounds: Using contaminated soaps on cuts, abrasions, or surgical wounds can lead to localized infections that may worsen if untreated.
Healthy individuals with minor skin lesions may experience localized infections, which are typically less severe but still require medical attention. Early intervention is key to preventing complications.
How to Stay Safe
To protect yourself and your family from potential risks associated with this recall, consider the following precautions:
Verify Your Products: Regularly check the products in your home or workplace against recall notices. Pay attention to lot numbers and expiration dates, as recalls often apply to specific batches.
Practice Good Hygiene: Use alternative, uncontaminated hand soaps and cleansers to maintain proper hygiene. Look for products from reputable manufacturers with clear labeling and no active recalls.
Stay Informed: Sign up for recall alerts from the FDA or trusted news sources to stay updated on product safety issues. Newsletters, such as those offered by local news outlets, can also provide timely updates.
Monitor Your Health: If you’ve used any of the recalled products, monitor for symptoms of infection, especially if you have a compromised immune system or chronic health condition.
The Bigger Picture: Product Safety and Recalls
This recall highlights the importance of rigorous quality control in the production of healthcare and personal care products. Contamination with bacteria like Burkholderia cepacia complex can occur during manufacturing, packaging, or storage, underscoring the need for manufacturers to adhere to strict safety standards. For consumers, staying informed about recalls and taking prompt action can prevent serious health consequences.
The FDA plays a critical role in overseeing product recalls and ensuring public safety. By reporting adverse reactions through programs like MedWatch, consumers can contribute to the identification and resolution of safety issues.
Conclusion
The DermaRite Industries recall of antiseptic and antimicrobial hand soaps is a reminder of the importance of product safety and consumer vigilance. While no infections have been reported to date, the potential for serious health risks, particularly for vulnerable populations, makes it essential to act quickly. By checking your inventory, disposing of affected products, and seeking medical advice if needed, you can help ensure your safety and that of others.
For the latest updates on this recall or to report issues, visit the FDA’s website or contact DermaRite Industries directly. Stay informed, stay safe, and take proactive steps to protect your health.
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