Vitruvias Therapeutics has “ceased operations” after voluntarily recalling a batch recall of generic thyroid tablets due to possible superpotency that could cause a range of adverse events.
Vitruvias Therapeutics is voluntarily recalling potentially superpotent tablets and states on its website that the business has ceased operations, transferring all its products to H2-Pharma.
The recall covers 3,655 units from a single lot of generic Thyroid Tablets, USP 30 mg, that Vitruvias distributed across the U.S. last year. The superpotent batch could cause overactive thyroid and lead to adverse events including weight loss, muscle weakness and rapid heart rate, the company said in its announcement this week.
Vitruvias’ tablets, which are produced from pig thyroid glands, are indicated for replacement or supplemental therapy in patients with hypothyroidism and for the treatment or prevention of euthyroid goiters.
Testing confirmed the potential for the recalled tablets to be superpotent. Consuming a superpotent product could cause overactive thyroid, leading to adverse events ranging from heat intolerance to heart rhythm disturbances.
The adverse events could be particularly harmful to seniors, pregnant women and infants, especially if they persist over an extended period of time. Seniors with high levels of thyroid hormones can suffer cardiac health problems, while overtreatment of hypothyroidism is linked to premature delivery and low birth weight in pregnant women and negative effects on infant development.
As of the Aug. 23 recall, Vitruvias hadn’t yet received any reports of adverse events related to superpotent tablets. The company has warned patients against stopping treatment without contacting their healthcare provider for guidance or for a replacement prescription.
Vitruvias is recalling the tablets with the FDA’s knowledge. The FDA published Vitruvias’ recall notice on its website without providing information beyond what the company shared in its statement. Vitruvias provided a company email and phone number for consumers with questions about the recall.
In 2018, Vitruvias raised $11.5 million in a series A round led by JW Asset Management and Perceptive Advisors. At the time, the company, which was founded in 2013, had recently received approval for its first drug submitted via the abbreviated new drug application pathway and was preparing to launch the product. Vitruvias was focused on technically difficult generic products, particularly sterile injectables.
The company was founded by Carl Whatley, who spent 21 years at Wyeth before launching and selling a series of businesses. After selling ProEthic Pharmaceuticals to Kowa Company in 2008, Whatley led Midlothian Laboratories to a takeover by Hi-Tech Pharmacal and went on to found Vitruvias.
