#US #Product Recall #North Bergen #DermaRite #Burkholderia cepacia

DermaRite Industries Initiates Nationwide Recall

In a recent announcement, DermaRite Industries, LLC has taken a proactive step by voluntarily recalling several hygiene products due to concerns over possible microbial contamination. The affected products, which include various formulations under the names DermaKleen, Dermasarra, Kleenfoam, and Perigiene, have been found to potentially contain Burkholderia cepacia, a bacterial strain that can cause serious infections, especially in vulnerable populations.

Understanding the Risks

Burkholderia cepacia complex can lead to severe infections, particularly in individuals with weakened immune systems or those suffering from chronic lung conditions. While healthy individuals may experience local infections, those who are immunocompromised face a heightened risk, which could escalate into life-threatening complications such as sepsis. To date, there have been no reported adverse events associated with this recall, but DermaRite is taking these precautionary measures seriously.

Product Information

The recall encompasses a range of products designed for hygienic purposes:

• - DermaKleen is an antiseptic lotion soap intended for handwashing and is infused with Vitamin E to help reduce skin bacteria.
• - Dermasarra serves as an external analgesic for temporary relief from itching associated with various skin irritations such as insect bites and sunburn.
• - KleenFoam is an antimicrobial foam soap aimed at minimizing bacteria during handwashing in medical contexts.
• - PeriGiene functions as an antiseptic cleanser formulated for use in sensitive perineal areas.

The products were distributed widely throughout the United States and in Puerto Rico, raising concerns over potential accessibility and usage in healthcare settings.

Recall Details

To assist consumers and healthcare facilities in identifying impacted products, DermaRite has provided detailed information on specific lot numbers and expiration dates. A complete list has been shared with distributors and included in communications to customers.

Consumers are urged to check their inventory and dispose of any products matching the recalled lot numbers. The company has facilitated easy communication through the following channels for consumers seeking further information:

• - Phone: Mary Goldberg at 973-569-9000 x104, available Monday to Friday from 9 AM to 5 PM EST.
• - Email: Customers may also reach out via email for queries.

Next Steps for Consumers

Individuals who have experienced any medical issues potentially related to these products are strongly encouraged to contact their healthcare provider. Further, any adverse effects or quality issues should be reported to the FDA's MedWatch program through their online portal, regular mail, or fax. It is critical that this information is documented for ongoing safety monitoring.

Conclusion

The recall by DermaRite Industries underscores the importance of product safety, especially in health-related items. The voluntary nature of this recall reflects a commitment to consumer health and safety, prioritizing transparency and responsible business practices in the face of potential public health threats. While no adverse events have been reported as of yet, the company’s swift action serves as a reminder of the paramount importance of hygiene and product integrity in healthcare settings.

For ongoing updates, consumers and healthcare facilities are advised to stay vigilant regarding product recalls and maintain open lines of communication with manufacturers.