Trinity HealthCare Supply, LLC dba altRx
FDA issued a warning letter to Trinity HealthCare Supply, LLC dba altRx (Miami, FL) for false or misleading marketing of compounded semaglutide and tirzepatide products on its website. The agency found that altRx's labeling falsely identified itself as the compounder of the drugs and that website claims describing GLP-1s as 'clinically proven' implied FDA approval for unapproved compounded products, violating FD&C Act sections 502(a) and 502(bb). FDA warned that failure to correct these violations could result in seizure and injunction, and required a written corrective response within 15 business days.
Flagged claims (2)
…clinically proven weight loss.
GLP-1s are clinically proven medications….
Required actions (4)
Send your written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)'s Office of Compliance at [email protected] within fifteen (15) business days of receipt of this letter.
Addressing other website claims that contain false or misleading representations about your compounded drug products or demonstrating that such claims have been modified or removed in light of FD&C Act §§ 502(a) and 502(bb) [21 U.S.C. §§ 352(a) and 352(bb)].
Identifying the entities that produce the compounded drug products offered on your website;
Providing a representative sample of labeling for such drug products;
Does your site contain similar claims?
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