Westminster Pharmaceuticals is voluntarily recalling some doses of two drugs used to treat hypothyroidism because active ingredients used in those pills were made at a plant in China that the U.S. Food and Drug Administration (FDA) recently warned has problems with quality and purity.
The recall applies only to levothyroxine and liothyronine tablets in 15 milligram (mg), 30 mg, 60 mg, 90 mg and 120 mg doses. The microgram (mcg) doses of these prescription drugs are not part of the recall. The recall notice says there have been no “adverse events” associated with the affected medicines and that patients should not stop taking the drugs until they contact their doctors.
Hypothyroidism is a condition in which the thyroid gland does not produce enough hormones to meet the body’s needs, leading to body functions slowing down. According to the National Library of Medicine, 4.6 percent of the U.S. population over the age of 12 has hypothyroidism, and women are more likely to have this condition than men.
In a June 22 letter to Sichuan Friendly Pharmaceutical Co. in Sichuan, China — the plant that makes the active ingredients — the FDA says that the agency issued an “import alert” for the company in March. The letter said: “Until you correct all deviations completely … the FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.”
Gajan Mahendiran, CEO of Westminster Pharmaceuticals, said in a statement on the company’s website: “While we stand behind the quality of our product, we are taking the utmost precaution by recalling our Thyroid, USP Tablets ... due to a recent inspection by the FDA at one of our active ingredient manufacturers.”
The FDA has posted the company’s announcement on its website. The notice includes the specific lot numbers and expiration dates of all the medications that are being recalled. Patients with questions or concerns can call Westminster toll-free at 888-354-9939. The company is fielding live calls Monday to Friday from 9 a.m. to 5 p.m. ET. Voicemail is available 24 hours a day, seven days a week.