The Food and Drug Administration (FDA) is reminding consumers not to use drugs, dietary supplements or medical device products distributed by Basic Reset or Biogenyx.
In September, a federal court ruled that the 2 companies needed to recall and discontinue distributing all of their products until they complied with the Federal Food, Drug, and Cosmetic Act. In total, 25 products were part of the recall. These included drugs, dietary supplements and devices that claimed to treat conditions such as inflammation, diarrhea, bacterial infections, head lice, allergies and pain. A full list of the products can be found here.
After multiple FDA inspections, the Agency sent a warning letter to the companies in 2016, however the violations in the letter were never corrected. The FDA also found that Basic Reset and Biogenyx unlawfully distributed dietary supplements that were adulterated and misbranded.
At this time, the Agency has not received any reports of adverse events related to the recalled products. Patients and physicians are encouraged to report any adverse events to the MedWatch program.
“We will continue to prevent the distribution of products that do not comply with applicable FDA requirements and ultimately place the public health at risk,” said Melinda K. Plaisier, FDA Associate Commissioner for Regulatory Affairs.
For more information visit fda.gov.