Ozempen.com
FDA issued a warning letter to Ozempen.com on June 24, 2024, for selling unapproved and misbranded semaglutide drug products ('4mg Semaglutide Pen' and '8mg Semaglutide Pen') to U.S. consumers over the internet without valid FDA-approved drug applications under section 505 of the FD&C Act. The site marketed these products as containing the 'same active ingredient as Ozempic, Rybelsus and Wegovy' while bypassing prescription requirements and omitting required safety warnings, including the black box warning for thyroid C-cell tumor risk. FDA demanded cessation of sales and a written corrective action response within 15 working days, warning that failure to comply could result in seizure and injunction.
Flagged claims (3)
4mg Semaglutide Pen
8mg Semaglutide Pen
Same active ingredient as Ozempic, Rybelsus and Wegovy, now more budget friendly.
Required actions (3)
FDA requests that www.ozempen.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers.
Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence.
Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction, without further notice.
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