Generics manufacturer Vitruvias Therapeutics has “ceased operations,” according to a note on its website, adding that its products are now are owned and distributed by H2-Pharma.
The shutdown of the private, 13-year-old Montgomery, Alabama, company coincided with a notice from Vitruvias on Friday of last week that it had recalled one lot of thyroid USP tablets because of their potential to be superpotent.
Twelve-year-old H2-Pharma, a private generics manufacturer based 55 miles to the northeast in Auburn, did not respond immediately to a request for comment.
In another update, following a pair of recalls earlier this week, Baxter has filed another recall with the FDA. The product pull covers two lots of 0.9% sodium chloride injection because of the potential presence of fiberglass in the solution.
The lot numbers are Y495523 and Y495523A and carry an expiration date of October 31, 2027. The product was distributed between July 31 and Aug. 3 of this year throughout the United States.
Like the other two recalls, the sodium chloride injection is packaged in Viaflex plastic containers. All three of the recalls were linked to the potential presence of particulate matter.
Baxter also is recalling one lot of anticoagulant sodium citrate after fiberglass was detected in the solution, and one lot of Dextrose Injection because of the potential presence of stainless steel particles.
Baxter’s recall of anticoagulant sodium citrate is for Lot Y493475, which was distributed between July 2-11 of this year and carries an expiration date of Dec. 31, 2027.
The product, intended for use with automated apheresis (blood-drawing) devices, prevents blood from clotting. Administration of the solution, which contains particulate matter, could lead to vein irritation, inflammatory or hypersensitivity reactions and embolization that could result in tissue or organ injury, Baxter said.
Baxter’s recall of Dextrose Injection covers lot Y495066, which carries an expiration date of July 31, 2027, and was distributed in the U.S. between July 25-28.
Dextrose Injection is used to supply body fluids and provide calories intravenously for patients who can’t eat or drink by mouth. Baxter has instructed facilities that used products from the lot to compound parenteral nutrition solutions to contact their patients and alert them to discontinue use and replace them.
Baxter warned of the potential for particulate matter to cause blockage and clotting in blood vessels which can cut off blood flow to vital organs and lead to a blood clot in the lungs, causing permanent organ damage or death.
With each of the products, Baxter said it is contacting customers by email and instructing them on how to identify affected lots. The company is asking customers to discontinue use and return all units. Baxter has not received adverse event reports on any of the recalled products.
As for Vitruvias’ fateful recall, the company said that recent testing showed the potential for its thyroid tablets to be superpotent, which could cause hyperthyroidism, leading to weight loss, heat intolerance, fatigue, nervousness, muscle weakness, hypertension, chest pain, rapid heart rate or heart rhythm disturbances. Those at a greater risk are the elderly, pregnant women and infants, Vitruvias said.
The recall concerns lot 504950, which carries an expiration date of Sept. 30 of this year. The 30 mg tablets were distributed between Jan. 31 and Sept. 30 of 2025, with 1,955 units sold among the 3,365 units that were released. There have been no reports of adverse events, the company said.