Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

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.

NDCProductLotExpiration
69367-159-04Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15mg X 100ct15918VP032/29/2020
15918VP022/29/2020
15918VP012/29/2020
159180073/31/2020
159180063/31/2020
159180052/29/2020
1591800412/31/2019
1591800312/31/2019
1591800212/31/2019
1591800112/31/2019
15917VP0310/31/2019
15917VP0210/31/2019
15917VP0110/31/2019
69367-155-04

Levothyroxine and Liothyronine (Thyroid Tablets, USP) 30mg X 100ct

15517VP018/31/2019
15517VP028/31/2019
15517VP038/31/2019
1551800112/31/2019
155180023/31/2020
69367-156-04Levothyroxine and Liothyronine (Thyroid Tablets, USP) 60mg X 100ct156180113/31/2020
156180092/29/2020
156180082/29/2020
1561800412/31/2019
1561800212/31/2019
15617VP0611/30/2019
15617VP0511/30/2019
15617VP0412/31/2019
15617VP037/31/2019
15617VP017/31/2019
15617VP-027/31/2019
69367-157-04Levothyroxine and Liothyronine (Thyroid Tablets, USP) 90mg X 100ct15717VP-017/31/2019
15717VP-027/31/2019
15717VP-037/31/2019
157180043/31/2020
1571700212/31/2019
69367-158-04Levothyroxine and Liothyronine (Thyroid Tablets, USP) 120mg X 100ct15817VP-019/30/2019
15817VP-029/30/2019
15817VP-039/30/2019
158180013/31/2020

Westminster is notifying its direct accounts by email and by phone to immediately discontinue distribution of the product being recalled and to notify their sub-wholesale accounts of this product recall and make arrangements for impacted product to be returned to Westminster. Instructions for returning recalled products are given in the Recall Notice Letter and Recall Response Form. Consumers that have these products which are being recalled should not discontinue use before contacting their physician for further guidance.

Customers and patients with medical-related questions, information about an adverse event or other questions about the Westminster’s product’s being recalled should contact Westminster’s Regulatory Affairs department by phone at: 888-354-9939

  • Live calls are received Monday-Friday, 9:00AM - 5:00PM EST with voicemail available 24 hours/day, 7 days/week or email This email address is being protected from spambots. You need JavaScript enabled to view it.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

 

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Read more https://www.fda.gov/Safety/Recalls/ucm616601.htm