The Food and Drug Administration late last year issued a warning letter to MedisourceRx, a compounding pharmacy owned by Hims & Hers, six months after a facility was cited for troubling problems during an inspection.
One violation involved a failure to report a serious adverse event experienced by a patient who had taken a compounded version of semaglutide, the chemical name for the Wegovy weight loss medication sold by Novo Nordisk, according to an FDA inspection report of the Los Alamitos, Calif., facility last May and June.
The incident occurred in January 2025, when a patient reported “severe” stomach issues and spent three nights in a hospital after taking the compounded injectable drug. But MedisourceRx, which Hims & Hers had acquired in September 2024, did not report the problem to the FDA within 15 days after receiving the information as required by law.Continue to STAT+ to read the full story…