www.24hreup.biz
FDA issued a warning letter to www.24hreup.biz, a Germany-based website, for selling unapproved and misbranded semaglutide drug products — marketed as 'Ozempic 0.5mg,' 'Ozempic 1mg,' and 'Rybelsus Semaglutide 14mg' — to U.S. consumers without a prescription and without FDA approval. The products violate the FD&C Act as unapproved new drugs and misbranded prescription drugs lacking adequate directions for use. FDA demands the site cease sales to U.S. consumers and respond within 15 working days, warning that failure to comply may result in seizure and injunction.
Flagged claims (3)
Ozempic 0.5mg
Rybelsus Semaglutide 14mg
Ozempic 1mg
Required actions (3)
FDA requests that www.24hreup.biz 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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