Thyroid medications recalled after failed FDA inspection

Following an FDA inspection, it’s been announced that some batches of hypothyroid medications produced by Westminster Pharmaceuticals are being recalled. The medication that’s being recalled contain levothyroxine (LT4) and liothyronine (LT3). These are synthetic thyroid hormones, and their function is to treat patients whose thyroid gland is failing to function properly.

The inspection of the company’s manufacturing plant took place earlier in the year. The FDA had warned that the plant wasn’t meeting the required standards in its manufacturing process. In a letter sent to the firm in June, the agency warned that if the issues highlighted weren’t corrected, it could “result in FDA continuing to refuse admission of articles manufactured.”

In the recall notice, the company noted that the products were being withdrawn due to the fact the issues raised “could represent the possibility of risk being introduced into the manufacturing process.” Although no adverse effects have been reported so far from the medication, Westminster Pharmaceuticals have recalled the products voluntarily out of caution, following the safety concerns raised in the inspection.

According to a statement from Gajan Mahendiran, who is the owner and CEO of Westminster Pharmaceuticals: “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.”

The recall affects 37 batches of the medication, including both levothyroxine and liothyronine of 15,30,60,90 and 120 milligrams. Full details of this can be found on the FDA’s website. The FDA has recommended that, as these medications are used to treat serious conditions, consumers should continue to take the medication and to seek advice from a doctor of pharmacist. In the meantime, the company has requested that its wholesale customers should stop providing new prescriptions for the pills that are affected.