TOPIC: Compunded Drugs by Fullerton Wellness: CDER Alert - Do Not Use Due to Sterility Concerns
AUDIENCE: Patient, Health Care Professional, Pharmacy
ISSUE: FDA is warning patients and health care professionals not to use drugs compounded and distributed by Fullerton Wellness LLC, Ontario, Calif., and distributed to patients by medical offices and clinics
Based on conditions observed by FDA and information provided by California regulatory authorities, FDA has concerns about the sterility of drugs distributed by Fullerton Wellness. Administration of a non-sterile drug intended to be sterile may result in serious and potentially life-threatening adverse health consequences including infections and sepsis.
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. On September 23, 2024, FDA received information from California regulatory authorities as part of ongoing collaboration between FDA and the state noting deficiencies found at Fullerton Wellness during a state inspection. After the state inspection, Fullerton Wellness voluntarily ceased operations.
On October 17, 2024, FDA joined California regulatory authorities at the Fullerton Wellness facility and observed conditions that could cause the drugs produced by the company to become contaminated. Fullerton Wellness used non-sterile ingredients to make these injectable drugs and took no steps to sterilize them which could introduce health risks.
FDA is not aware of any adverse reactions associated with the use of compounded drugs from Fullerton Wellness. However, compounders that are not registered with FDA as outsourcing facilities are primarily overseen by state regulators and are not required under federal law to report adverse events to FDA.
For more information about this alert, click on the red button "Read Alert" below.
BACKGROUND: Fullerton Wellness is a facility that compounds drugs intended to be sterile, including semaglutide and tirzepatide injections.
RECOMMENDATIONS:
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Health care professionals should immediately check their medical supplies, quarantine any drug products from Fullerton Wellness, and not administer them.
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Patients who have received compounded drugs distributed by Fullerton Wellness should stop using them and contact their health care professional.
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