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.
To date, Westminster Pharmaceuticals has not received any reports of adverse events related to this product.
Levothyroxine and Liothyronine (thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands. Thyroid tablets contain both tetraiodothyronine sodium (T4 levothyroxine) and liothyronine sodium (T3 liothyronine). Levothyroxine and Liothyronine tablets (thyroid tablets, USP) are indicated as replacement or supplemental therapy in patients with hypothyroidism. Appropriate adjustments of the various therapeutic measures directed at these concomitant endocrine diseases are required. Thyroid is not associated with serious adverse reactions and does not have a known tumorigenic potential.
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.
The products subject to recall are packed in 100-count bottles. To best identify the product the NDC’s, Product Description, Lot numbers and Expiration dates are listed below. These lots were distributed nationwide in the USA to Westminster’s direct accounts.
NDC and Product
69367-159-04 Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15mg X 100ct
Lot Expiration
15918VP03 2/29/2020
15918VP02 2/29/2020
15918VP01 2/29/2020
15918007 3/31/2020
15918006 3/31/2020
15918005 2/29/2020
15918004 12/31/2019
15918003 12/31/2019
15918002 12/31/2019
15918001 12/31/2019
15917VP03 10/31/2019
15917VP02 10/31/2019
15917VP01 10/31/2019
NDC and Product
69367-155-04 Levothyroxine and Liothyronine (Thyroid Tablets, USP) 30mg X 100ct
Lot Expiration
15517VP01 8/31/2019
15517VP02 8/31/2019
15517VP03 8/31/2019
15518001 12/31/2019
15518002 3/31/2020
NDC and Product
69367-156-04 Levothyroxine and Liothyronine (Thyroid Tablets, USP) 60mg X 100ct 15618011 3/31/2020
Lot Expiration
15618009 2/29/2020
15618008 2/29/2020
15618004 12/31/2019
15618002 12/31/2019
15617VP06 11/30/2019
15617VP05 11/30/2019
15617VP04 12/31/2019
15617VP03 7/31/2019
15617VP01 7/31/2019
15617VP-02 7/31/2019
NDC and Product
69367-157-04 Levothyroxine and Liothyronine (Thyroid Tablets, USP) 90mg X 100ct 15717VP-01 7/31/2019
Lot Expiration
15717VP-02 7/31/2019
15717VP-03 7/31/2019
15718004 3/31/2020
15717002 12/31/2019
NDC and Product
69367-158-04 Levothyroxine and Liothyronine (Thyroid Tablets, USP) 120mg X 100ct 15817VP-01 9/30/2019
Lot Expiration
15817VP-02 9/30/2019
15817VP-03 9/30/2019
15818001 3/31/2020
People with concerns or questions should contact their pharmacy to assure their medications do not fall within this recall alert.
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