News

Westminster Pharmaceuticals Voluntarily Recalls Thyroid Tablets

No adverse events have reported from the affected pills, but some ingredients were produced in a factory that the FDA has since cited for lax laboratory protocols.

Published Aug 15, 2018

Updated Aug 17, 2018

On 9 August 2018, Westminster Pharmaceuticals announced that they were issuing a voluntary recall of their "Thyroid Tablets, USP", a combination drug containing levothyroxine (LT4), and liothyronine (LT3), which are synthetic versions of thyroid hormones and used to treat hypothyroidism. The concern stemmed from an alert the U.S. Food and Drug Administration (FDA) issued in March 2018 regarding a Chinese company named Sichuan Friendly Pharmaceutical Co., which produced pharmaceutical ingredients used in the drugs produced by Westminster:

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 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 FDA issued an Import Alert regarding Sichuan Friendly in March 2018. Such alerts “inform FDA field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of FDA laws and regulations.” In their warning letter to Sichuan Friendly issued 22 June 2018, the FDA cited a lack of protocols to test for residual solvent in their final products, lax procedures and record keeping for the cleaning and maintenance of their laboratory equipment, and the company’s failure to develop a method to test the long-term stability of their product.

The recall is a precautionary measure; Westminster Pharmaceuticals stated that they have received no notice of adverse events from the affected products, and points out that people should not cease taking the affected drugs, but to continue them until a replacement arrives:

Because these products may be used in the treatment of serious medical conditions, patients taking the recalled medicines should continue taking their medicine until they have a replacement product.

Consumers who are concerned that they may possess such a recalled medicine can check the FDA notice to see if their pills come from one of the affected batches.

Sources

U.S. Food and Drug Administration.   "Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration."     9 August 2018.

U.S. Food and Drug Administration.   "Warning Letter 320-18-59."     22 June 2018.

Updates

Update [17 August 2018]: Added clarifying information about Thyroid Tablets, USP.

Alex Kasprak is an investigative journalist and science writer reporting on scientific misinformation, online fraud, and financial crime.

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