FDA Recalls 2 Thyroid Medications Due to Impurity Risk
Check your medicine cabinets! If you take a daily pill for a thyroid condition, you might need to order replacement medication.
According to the US Food and Drug Administration website, Westminster Pharmaceuticals has recalled all unexpired lots of levothyroxine and liothyronine (thyroid tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, and 120 mg to the wholesale level.
These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Manufacturing Practices (cGMP). Substandard cGMP practices could represent the possibility of risk being introduced into the manufacturing process.
The tablets that are subject to recall are packed in 100-count bottles and expire in 2019 and 2020. To find the full list of recalled products, be sure to check out the lot numbers and expiration dates in the chart over on the FDA’s website.
Patients who take thyroid medication are being directed to continue daily use of their medication until they have a replacement. The recall is voluntary and there have so far been no reported adverse reactions to the recalled medication. And because this medication is used to treat serious medical conditions, it’s important to not discontinue use unless otherwise directed by your doctor.
Anyone with questions about Westminster’s product’s being recalled should contact Westminster’s Regulatory Affairs department by phone at 888-354-9939.