DermaRite Industries LLC recalled 249 bottles of DermaSarra External Analgesic on July 17, 2025. The product contains camphor and is contaminated with Burkholderia cepacia. This recall is classified as Class I due to the potential health risks.
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Consumers and healthcare providers should stop using this product immediately. Contact DermaRite Industries, LLC or your healthcare provider for guidance. Notification method: Letter
The recall involves DermaSarra External Analgesic, containing 0.5% camphor in 222 mL bottles. The affected lot number is 40187.2, with an expiration date of February 2026. The product was distributed nationwide in the USA.
The product is contaminated with Burkholderia cepacia, a type of bacteria that can cause serious infections, particularly in individuals with weakened immune systems. The contamination poses a high health risk.
No specific incidents have been reported at this time. However, Burkholderia cepacia can lead to severe respiratory infections and other complications.
Consumers should stop using this product immediately. Contact DermaRite Industries, LLC or your healthcare provider for further guidance.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0611-2025. Alternatively, consumers can reach out to DermaRite Industries at their North Bergen, NJ address.
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