Vitruvias Therapeutics has recalled one lot of thyroid medication after FDA testing found potential “superpotency.”
The Auburn, Alabama-based company voluntarily pulled Lot 504950 of Thyroid Tablets, USP 30 mg at the consumer level, according to a company announcement the FDA published Monday. The recall covers 3,655 units released by the company, of which 1,955 were sold.
Taking superpotent thyroid tablets can cause hyperthyroidism, or an overactive thyroid, Vitruvias Therapeutics warned. The company listed symptoms including weight loss, heat intolerance, fatigue, nervousness, muscle weakness, high blood pressure, chest pain, rapid heart rate and heart rhythm disturbances.
Elderly patients, pregnant women and infants face greater risks from excessive thyroid hormone levels, particularly with extended use, the company said. Excess thyroid hormone has been associated with cardiac problems in elderly patients, while overtreatment during pregnancy has been associated with premature delivery and low birth weight. In infants, overtreatment may negatively affect growth and development.
Vitruvias Therapeutics said it has not received any reports of adverse events known to be connected to the recall.
The recalled product carries NDC 69680-166-00 and an expiration date of Sept. 30. The affected lot was distributed nationwide to the company’s direct accounts between Jan. 31, and Sept. 30.
Thyroid, USP is derived from porcine thyroid glands and contains levothyroxine and liothyronine. The medication is used to treat hypothyroidism, or an underactive thyroid.
Vitruvias Therapeutics is notifying wholesalers to stop distributing the recalled product and arranging for its destruction. Patients currently taking tablets from the affected lot should not stop taking the medication without first contacting their healthcare provider for guidance or a replacement prescription, the company said.
A representative for Vitruvias Therapeutics did not immediately respond to FOX Business’ request for additional information.
Consumers with questions can contact Vitruvias Therapeutics at [email protected] or at 256-239-9373. Anyone who has experienced problems that may be connected to the medication should contact a physician or healthcare provider.
The recall is being conducted with the knowledge of the FDA.