Recalled Thyroid Drugs Contain Inconsistent Levels Of Active Ingredients, FDA Confirms

Federal health officials are warning drug distributors not to send out certain recalled thyroid drugs, after laboratory testing confirmed the active pharmaceutical ingredients (API) had inconsistent levels, which may pose a risk of permanent and life-threatening injuries. 

The FDA issued a thyroid drug alert on August 17, warning repackagers and distributors, finished drug manufacturers and compounders that porcine thyroid pills manufactured by Sichuan Friendly’s Pharmaceutical Co. Limited of China were tested and found to have inconsistent levels of the active ingredients levothyroxine and liothyronine.

The issue was first recognized earlier this month, when the FDA announced a Levothyroxine and Liothyronine thyroid drug recall, after finding the thyroid medications contain active ingredients that were flagged in 2017, during an FDA inspection that discovered deficiencies with Current Good Manufacturing Practices (cGMP). The notice indicated the substandard manufacturing processes could present a risk of injury or illnesses to patients receiving the medication. The FDA issued issued an import alert based on their findings of the cGMP violations in March.

The recalled Levothyroxine and Liothyronine are used to make treatments for patients with hypothyroidism, a condition in which the thyroid gland doesn’t produce enough thyroid hormone.

FDA testing determined the recalled thyroid drugs contained inconsistent levels of  levothyroxine and liothyronine, and should not be used to manufacture or compound drugs for patients. The over or under treatment of hypothyroidism could result in permanent of life-threatening adverse health consequences.

The FDA indicates it has confirmed that Sichuan Friendly’s Pharmaceutical Co. is the source of the inconsistent active ingredients. It warns that some of the pills are still on the U.S. market. According to the recall, the ingredients may have been repacked or relabeled before being further distributed without any source identification.

Officials are warning manufacturers and compounders who maker levothyroxine and liothyronine drug products to contact their ingredient supplier to verify the source of the thyroid ingredients before any further manufacturing, distributing or sale.

Manufacturers and compounders are being instructed to quarantine any known Sichuan Friendly ingredients and associated drug products.

To date, only Westminster Pharmaceuticals, LLC has issued a recall for certain thyroid medications that could be subject to the inconsistent levels of API.

The recalled Westminster Pharmaceutical thyroid tablets include Levothyroxine and Liothyronine 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg doses. The medications were distributed throughout the United States to Westminster direct accounts.