A nationwide recall has been issued for one lot of Vitruvias Therapeutics’ Thyroid Tablets, USP 30 mg after the medication was found to have the potential to be “superpotent.” The Vitruvias Therapeutics hyperthyroidism risk recall follows concerns that excessive levels of thyroid hormones could be present in the affected tablets, potentially increasing the risk of hyperthyroidism and other health complications.
The recall affects Lot No. 504950, identified by NDC 69680-166-00, with an expiration date of September 30, 2026. The FDA said 3,655 units from the affected lot were released, while 1,955 units were sold. The recalled medication was distributed nationwide through Vitruvias Therapeutics’ direct accounts.
Why the Tablets Were Recalled
The medication is a natural thyroid preparation made from porcine thyroid glands and contains levothyroxine and liothyronine. It is prescribed for people with hypothyroidism, a condition in which insufficient thyroid hormone is produced by the body.
The recall was initiated after testing showed that the tablets could contain higher-than-expected levels of thyroid hormones. If excessive thyroid hormone is taken, symptoms associated with hyperthyroidism may develop. Those symptoms can include a rapid or irregular heartbeat, chest pain, nervousness, fatigue, muscle weakness, heat intolerance, high blood pressure and unexplained weight loss.
Greater risks may be faced by older adults, pregnant women and infants. Serious complications can occur when excessive thyroid hormone exposure is sustained, making proper identification of the recalled product particularly important.
What Patients Should Do
Patients who use Thyroid Tablets, USP 30 mg have been advised to check their medication packaging for Lot No. 504950. Wholesalers and direct customers have been notified by Vitruvias Therapeutics, and arrangements have been made for affected products to be removed from distribution and destroyed.
Patients should not stop taking their thyroid medication without first speaking with a healthcare professional. Doctors and pharmacists can determine whether a replacement medication is needed and provide instructions for continuing treatment safely.
At the time of the recall announcement, no adverse events associated with the affected lot had been reported to the company. Anyone who experiences a suspected reaction or believes there is a problem with the medication should contact a healthcare provider.
The FDA’s MedWatch program can also be used by consumers and medical professionals to report suspected adverse reactions or product-quality concerns. The recall serves as a reminder that medication labels and lot numbers should be checked whenever a safety alert is issued.
Source : wthr.com

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