Drug Safety Alerts

Levothyroxine and Liothyronine tablets Recall

8/17/18

On August 17, 2018, the United States Food and Drug Administration (FDA) issued a notice regarding a recall of all lots of levothyroxine and liothyronine tablets manufactured by Westminster Pharmaceuticals. This recall was originally issued as a precaution because the products 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). Sichuan Friendly Pharmaceutical Co. Limited, China recalled certain lots of porcine thyroid API due to inconsistent quality of the API. The FDA recommends that manufacturers and compounders not use Sichuan Friendly’s porcine thyroid API received since August 2015. This thyroid API comes from porcine (pig) thyroid glands and is used to make a non-FDA approved drug product, composed of levothyroxine and liothyronine, to treat hypothyroidism (underactive thyroid).

On August 17, 2018, the FDA reported that its laboratory testing confirmed inconsistent levels of levothyroxine and liothyronine in Westminster Pharmaceuticals’ levothyroxine and liothyronine products. The FDA recommends patients not use porcine thyroid drug products made by Westminster. The FDA also recommends that patients discuss FDA-approved hypothyroidism treatment options with their doctors, as combination levothyroxine and liothyronine products are not FDA-approved.

A complete list of the affected products is provided here:

CVS Caremark Response: Because of this action, CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking levothyroxine and liothyronine tablets to contact their prescriber.

For more information about this recall, health care providers may contact the Westminster Regulatory Affairs department at 1‑888-354-9939 or visit www.wprx.com/. You may also call the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit www.fda.gov/Drugs/DrugSafety/ucm617287.htm.