Vitruvias Therapeutics is recalling one lot of Thyroid Tablets USP 30 mg because testing confirmed the potential for the tablets to be superpotent, according to a U.S. Food and Drug Administration safety notice. The recall covers lot number 504950 and was issued nationwide. The Vitruvias Therapeutics superpotent medication recall is limited to the identified lot.
The FDA’s MedWatch bulletin said taking tablets with more thyroid hormone than intended can cause hyperthyroidism, or an overactive thyroid. The notice lists possible symptoms and complications including weight loss, heat intolerance, fatigue, nervousness, muscle weakness, high blood pressure, chest pain, rapid heart rate and heart-rhythm disturbances.
The regulator said older adults, pregnant women and infants face greater risk, particularly if exposure continues for an extended period. The FDA recall listing identified the product and potential potency problem, while the MedWatch notice supplied the lot number and risk statement. Patients and healthcare professionals should check their supply against the recall notice and contact a pharmacist or prescriber for product-specific advice. People should not stop a prescribed thyroid medicine without medical guidance, because treatment changes also carry risks. The notice concerns the identified lot, not every thyroid product on the market.
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