FDA

FDA issues alert on using compounded drugs from Fullerton Wellness

November 6, 2024

On November 1, FDA issued a warning against the use of compounded drugs from Fullerton Wellness LLC in Ontario, California, due to concerns about sterility. This facility produces sterile injectable medications, including semaglutide and tirzepatide, but recent inspections revealed significant contamination risks, including the use of non-sterile ingredients.

On August 14, 2024, a patient reported seeing a black particulate in a vial of semaglutide. Following a state inspection, Fullerton Wellness voluntarily ceased operations. FDA, in collaboration with California regulators, confirmed conditions that could lead to contamination. Fullerton Wellness used non-sterile ingredients to make these injectable drugs and took no steps to sterilize them, which could introduce health risks.

FDA urges healthcare professionals to immediately check their supplies, quarantine any Fullerton Wellness products, and refrain from administering them. Patients should discontinue use and consult their healthcare provider. While no adverse reactions have been reported, compounded drugs from unregistered facilities are primarily regulated by state authorities and aren't required to report adverse events to the FDA.

Source:

FDA. (2024, November 1). FDA warns patients and health care professionals not to use compounded drugs from Fullerton Wellness. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-patients-and-health-care-professionals-not-use-compounded-drugs-fullerton-wellness