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CRITICALPharmacy / Compounding

Get.Fit.Medical, LLC dba Get.Fit.Medical

FDA issued a warning letter to Get.Fit.Medical, LLC on September 9, 2025, after reviewing its website and finding that the telehealth company marketed compounded sildenafil, tadalafil, semaglutide, and tirzepatide using brand-name equivalency claims such as 'GENERIC VIAGRA,' 'GENERIC OZEMPIC/WEGOVY,' and 'GENERIC MOUNJARO.' These claims falsely implied the compounded products were the same as FDA-approved drugs, constituting misbranding under FDCA sections 502(a) and 502(bb). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

TADALAFIL (GENERIC CIALIS)

TIRZEPATIDE (GENERIC MOUNJARO)

SILDENAFIL (GENERIC VIAGRA)

SEMAGLUTIDE (GENERIC OZEMPIC/WEGOVY)

You should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product).

Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)'s Office of Compliance describing the specific steps you have taken to address any violations.

Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.

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