MEDIUMRegulatoryTier 1

Vitruvias Therapeutics, Inc Issues Nationwide Recall of One Lot of Thyroid Tablets, USP 30 mg Due to Potential Super Potency

SourceFDA RecallsTier 1Hard News

By FDA

Originally at fda.gov

Summary & scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol (Drill-Down Score) — not the original publisher.

Why it matters for dental

Dental practices that dispense or prescribe compounded thyroid tablets for patients with hypothyroidism should immediately quarantine and return Lot 504950 30 mg tablets, as super-potency could trigger arrhythmias or angina that complicate in-office procedures.

Key points

  • Recall affects one specific lot (Lot No. 504950) of Thyroid Tablets, USP 30 mg; all other lots are unaffected.
  • Super-potent thyroid hormone can increase heart rate and blood pressure—heightening risk of cardiac events during local-anesthetic or sedation dentistry.
  • Action required: inspect inventory, isolate lot 504950, and follow return instructions; no FDA enforcement action is indicated at this time.
  • Practices with in-house pharmacies or dispensing programs bear primary compliance responsibility for patient notification and retrieval.

Who should care

OwnerStaff

Read the original on FDA Recalls

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