Two thyroid medications recalled by FDA

By Dr. Ananya Mandal, MDAug 16 2018

The United States Food and Drug Administration (FDA) have announced the recall of two thyroid medications due to issues with their ingredients.

Westminster Pharmaceuticals has recalled the Levothyroxine and Liothyronine tablets as a precautionary measure says the FDA statement.

The FDA states that these medications had to be recalled because, “they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA's import alert.”

Patients taking these medications however are instructed to continue taking them until they have been given a replacement.

The FDA statement says that Westminster Pharmaceuticals has been recalling all lots of the said tablets within their expiry dates. Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg have been recalled to the whole sale level.

The ingredients used to make these tablets have been found to be sourced before the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd.

These were thus found to be deficient of the Current Good Manufacturing Practices (cGMP). Lower standards of manufacturing process can put the preparation at risk says the FDA.

There have been no reports of any side effects or adverse events among the users of these medications however.

Levothyroxine and Liothyronine (thyroid tablets, USP) are oral tablets that contain thyroid hormone thyroxine. They contain tetraiodothyronine sodium (T4 levothyroxine) and liothyronine sodium (T3 liothyronine).

These are prescribed for regular use among patients with underactive thyroid glands or hypothyroidism. There are no serious adverse effects of these medications and they are to be used by the consumers until they are replaced suitably. Stopping them could be dangerous.

Westminster Pharmaceuticals owner and CEO Gajan Mahendiran has said in a statement,

“Westminster Pharmaceuticals aims to ensure that integrity is embedded in our reputation through the products we develop and market. We will never compromise when it comes to providing our patients with the caliber of medication they deserve. While we stand behind the quality of our product, we are taking the utmost precaution by recalling our Thyroid, USP Tablets only to the wholesale level due to a recent inspection by the FDA at one of our active ingredient manufacturers.”

At present the recall is for 100-count bottles. Some of the lot numbers and Expiration dates include Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15mg X 100ct (lot numbers 15918VP03, 15918VP02, 15918VP01, 15918007, 15918006, 15918005, 15918004, 15918003, 15918002, 15918001, 15917VP03, 15917VP02, 15917VP01), Levothyroxine and Liothyronine (Thyroid Tablets, USP) 30mg X 100ct (lot numbers 15517VP01, 15517VP02, 15517VP03, 15518001, 15518002), Levothyroxine and Liothyronine (Thyroid Tablets, USP) 60mg X 100ct (Lot numbers 15618011, 15618009, 15618008, 15618004, 15618002, 15617VP06, 15617VP05, 15617VP04, 15617VP03, 15617VP01, 15617VP-02), Levothyroxine and Liothyronine (Thyroid Tablets, USP) 90mg X 100ct (Lot numbers 15717VP-01, 15717VP-02, 15717VP-03, 15718004, 15717002) and Levothyroxine and Liothyronine (Thyroid Tablets, USP) 120mg X 100ct (Lot numbers 15817VP-01, 15817VP-02, 15817VP-03, 15818001).

Westminster at present is notifying the distributers directly by email and phone to stop the distribution of these lots of medications. The impacted products are to be soon returned to Westminster.

The instructions for recall are sent in the Recall Notice Letter and Recall Response Form. Consumers are directed to call Westminster’s Regulatory Affairs department by phone at: 888-354-9939 (live calls Monday-Friday, 9:00AM - 5:00PM EST with voicemail available 24 hours/day, 7 days/week) or email [email protected] for further queries says the FDA statement.