CALIFORNIA – The Food and Drug Administration (FDA) issued a warning to consumers, November 1, not to use drugs – including Ozempic and Wegovy compounded and distributed by Fullerton Wellness LLC in Ontario, California.
The FDA says that using a non-sterile drug can lead to life-threatening health problems, like infections or sepsis. This is because non-sterile drugs may contain harmful germs or particles that can cause severe reactions in the body.
Black particulate in a vial
Fullerton Wellness is a facility that compounds sterile drugs, including semaglutide injections – the active ingredient in Ozempic and Wegovy. They also compound tirzepatide injections found in Mounjaro.
All three drugs are primarily used for managing Type 2 diabetes.
The FDA says they have concerns about the sterility of drugs distributed by Fullerton Wellness.
“On August 14, 2024, FDA received a complaint from a patient who noticed a black particulate in a vial of semaglutide distributed by Fullerton Wellness,” says the FDA news release.
A month later, the FDA says they received information from California regulatory authorities noting deficiencies found at the facility during a state inspection.
After the state inspection, Fullerton Wellness voluntarily ceased operations.
Quarantine drug products from Fullerton Wellness
The FDA says in October 2024, after an inspection of the facility, they determined that Fullerton Wellness used non-sterile ingredients to make these injectable drugs and took no steps to sterilize them which could introduce health risks.
“Health care professionals should immediately check their medical supplies, quarantine any drug products from Fullerton Wellness, and not administer them,” said the FDA in the news release.
In addition, patients who have received compounded drugs distributed by Fullerton Wellness should stop using them and contact their health care professional.
FDA is not aware of any adverse reactions
The FDA is not aware of any adverse reactions associated with the use of compounded drugs from Fullerton Wellness.
Patients and health care professionals should report any adverse reactions to FDA’s MedWatch program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm
- Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178.
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