Westminster Pharmaceuticals, LLC and CVS Pharmacy, Inc. are on the receiving end of a proposed class action lawsuit that alleges the companies have manufactured and sold adulterated generic thyroid medications. According to the lawsuit, the medicines at issue are Westminster’s “Thyroid Tablets, USP” and “Thyroid Tablets”—generic drugs containing Levothyroxine and Liothyronine that are used to treat thyroid disorders.
In August 2018, the suit says, the U.S. Food & Drug Administration (FDA) announced Westminster’s voluntary recall of the products, with the manufacturer noting that its supplier, Sichuan Friendly Pharmaceutical Co., Ltd., had received a negative FDA inspection. The inspection reportedly revealed that the company’s active pharmaceutical ingredients (API), including levothyroxine and liothyronine, were adulterated due to several issues in its manufacturing process, including that Sichuan had:
failed to ensure that “all specifications and test procedures are scientifically sound and appropriate”;
manufactured certain API on shared equipment;
failed to establish written procedures for equipment cleaning and maintenance;
not provided data that supported “the shelf-life labeling of certain products”; and
used a non-validated and non-password-protected Excel spreadsheet to make certain calculations for “product release and stability testing” that contained incorrect and unlocked formulas.
The lawsuit charges that Westminster and CVS are liable for respectively manufacturing and selling thyroid medication that contained the adulterated API.
“These medications are worthless,” the complaint reads, “as they are manufactured with APIs that have been found to be adulterated and are not fit for human consumption.”