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This inspection found that compounded drug labels lacked mandatory information required under Section 503B, specifically the statement "Office Use Only." The labeling omission affected multiple sterile injectable batches, including semaglutide and tirzepatide vials
Feb 22, 2026 Before you inject another dose from that unmarked vial, stop
It is important to note that compounded semaglutide is not FDA-approved, and the FDA has not reviewed these formulations for safety, effectiveness, or quality
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