Thyroid medications recalled voluntarily by manufacturer after FDA issues warning to Chinese manufacturing supplier.
Certain batches of hypothyroid medications are being recalled by Westminster Pharmaceuticals after one of its Chinese suppliers failed a US Food and Drug Administration inspection.
The medication in question contains a combination of levothyroxine, called LT4, and liothyronine, called LT3. Both are synthetic thyroid hormones used when a person's thyroid gland is no longer functioning properly.
"While we stand behind the quality of our product, we are taking the utmost precaution by recalling our Thyroid, USP Tablets only to the wholesale level due to a recent inspection by the FDA at one of our active ingredient manufacturers," Westminster Pharmaceuticals owner and CEO Gajan Mahendiran said in a statement.
The FDA inspected the Sichuan Friendly Pharmaceutical Co.'s manufacturing plant in October. In a letter dated June 22, the agency informed the Chinese company that the plant was not meeting its good manufacturing process standards. If the company fails to correct those issues, the letter warned, it could "result in FDA continuing to refuse admission of articles manufactured."
No adverse effects from these medications had been reported as of August 9, Westminster Pharmaceuticals said; instead, the lots were being recalled out of an abundance of caution.
Because thyroid medications can treat serious disease, the FDA recommends that consumers continue to take the pills until they can contact their physician or pharmacist for further guidance.
The recall affects 37 unexpired lots of levothyroxine and liothyronine (Thyroid Tablets, USP) 15, 30, 60, 90 and 120 milligrams. The company is reaching out to all wholesale customers to ask them to stop filling prescriptions with the affected pills, which are sold in 100-count bottles.