#United States #Product Recall #DermaRite #Burkholderia #North Bergen, NJ

DermaRite Industries Expands Nationwide Product Recall

DermaRite Industries, LLC has recently announced an expansion of a previously initiated voluntary recall from July 16. This action has been taken due to the identification of potential microbial contamination linked to the Burkholderia cepacia complex in several of its products. The company emphasizes the importance of this recall as a precautionary measure to protect consumers, especially vulnerable populations.

Nature of the Contamination

Burkholderia cepacia can be a particular threat to immunocompromised individuals or those caring for them. For such individuals, using affected products could lead to severe and life-threatening infections. Even for healthy persons with minor skin issues, utilizing these contaminated products could result in localized infections. The risk amplifies significantly for immunocompromised patients, as the infection could escalate, potentially causing life-threatening sepsis.

Recalled Products

The products involved in this expanded recall encompass a range of skin care and antiseptic items. Notable mentions include:

• - 4-N-1 Wash Cream: A no-rinse product designed to protect and relieve chafed or cracked skin.
• - DermaCerin: A moisturizing cream intended to alleviate dry or cracked skin, particularly useful in harsh weather conditions.
• - DermaFungal: An over-the-counter antifungal cream meant for treating various skin conditions such as athlete's foot and jock itch.
• - DermaKleen: An antiseptic lotion soap aimed at reducing skin bacteria during handwashing.
• - Gel Rite: A hand sanitizer with Vitamin E.

The full list of affected products and their respective lot numbers can be accessed through the DermaRite website.

Call to Action for Consumers

DermaRite has reached out to their distributors and customers urging them to check their inventory thoroughly. They are instructed to destroy any recalled products following proper facility procedures. Consumers who may possess these products should refrain from using them and should contact their healthcare provider if they have experienced any health issues related to these items.

For inquiries or additional information about the recall, concerned consumers are encouraged to reach out to Sedgwick at 888-943-5190, available Monday to Friday, from 8 AM to 5 PM EST. Additionally, anyone affected by adverse reactions from these products is advised to report them through the FDA’s MedWatch program, a vital system for ensuring consumer safety.

Corporate Responsibility and Follow-Up

This recall is conducted in conjunction with the oversight of the U.S. Food and Drug Administration (FDA), ensuring that the necessary measures are taken to safeguard public health. DermaRite Industries continues to monitor the situation closely and is committed to maintaining high standards in product safety and consumer health.

In conclusion, product recalls serve as an important reminder of the potential risks associated with microbial contamination and highlight the necessary precautions consumers should take when they become aware of potential threats. DermaRite Industries urges all customers to be vigilant and to follow the recommended actions regarding the recalled items.