The FDA issued a warning to patients and healthcare professionals to refrain from using compounded drugs distributed by Ontario, Calif.-based Fullerton Wellness, expressing concerns about the sterility of the drugs following reports of contamination.
The warning follows a patient complaint Aug. 14 about black particulate matter found in a vial of semaglutide, according to a Nov. 1 news release from the agency. Subsequent inspections by California regulatory authorities revealed deficiencies at Fullerton Wellness, prompting the facility to voluntarily cease operations Sept. 23.
A follow-up inspection Oct. 17 uncovered practices that could lead to drug contamination, including the use of non-sterile ingredients without proper sterilization.
The agency urged healthcare professionals to check their supplies, quarantine any drugs from Fullerton Wellness and avoid administering them. Patients who have received the compounded drugs were advised to stop using them and consult healthcare providers.