MN084 FDA Issues Recall of Levothyroxine (Thyroid Tablets)

Medicare Nation

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The FDA has issued a "Voluntary Recall" on Westminster Pharmaceuticals of all lots of their Levothyroxine and Liothyronine (Thyroid Tablets).

Westminster Pharmaceuticals, LLC, which has its Corporate HQ in Tampa, Florida, is voluntarily recalling all lots, within the expiration date, of Levo-thyroxine and Lio-thyronine (Thyroid Tablets) dosages of 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg up to the wholesale level.

These products are being recalled by Westminster Pharmaceuticals 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 is out of China.

The Recall comes as a result of a 2017 inspection where deficiencies were found 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 tetra-io-do-thyronine sodium (T4 levothyroxine) and lio-thy-ronine sodium (T3 liothyronine).

Levothyroxine and Liothyronine tablets (thyroid tablets, USP) are indicated as replacement or supplemental therapy in patients with hypothyroidism.

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.

According to the U.S. Food & Drug Administration Report.....

[8/17/2018] FDA is alerting active pharmaceutical ingredient (API) repackagers and distributors, finished drug manufacturers, and compounders that Sichuan Friendly Pharmaceutical Co. Limited, China, is recalling certain lots of porcine thyroid API due to inconsistent quality of the API. FDA recommends that manufacturers and compounders not use Sichuan Friendly’s porcine thyroid API received since August 2015. This thyroid API comes from porcine (pig) thyroid glands and is used to make a non-FDA approved drug product, composed of levothyroxine and liothyronine, to treat hypothyroidism (underactive thyroid).

FDA laboratory testing confirmed the Sichuan Friendly API has inconsistent levels of the active ingredients – levothyroxine and liothyronine – and should not be used to manufacture or compound drugs for patient use. Risks associated with over or under treatment of hypothyroidism could result in permanent or life-threatening adverse health consequences.

These lots were distributed nationwide in the USA to Westminster’s direct accounts.

These lots were distributed nationwide in the USA

NDC Product Lot Expiration 69367-159-04 Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15mg X 100ct 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 69367-155-04

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

15517VP01 8/31/2019 15517VP02 8/31/2019 15517VP03 8/31/2019 15518001 12/31/2019 15518002 3/31/2020 69367-156-04 Levothyroxine and Liothyronine (Thyroid Tablets, USP) 60mg X 100ct 15618011 3/31/2020 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 69367-157-04 Levothyroxine and Liothyronine (Thyroid Tablets, USP) 90mg X 100ct 15717VP-01 7/31/2019 15717VP-02 7/31/2019 15717VP-03 7/31/2019 15718004 3/31/2020 15717002 12/31/2019 69367-158-04 Levothyroxine and Liothyronine (Thyroid Tablets, USP) 120mg X 100ct 15817VP-01 9/30/2019 15817VP-02 9/30/2019 15817VP-03 9/30/2019 15818001 3/31/2020

Westminster is notifying its direct accounts by email and by phone to immediately discontinue distribution of the product being recalled.

The FDA Advises Consumers who have the recalled products, should not discontinue use before contacting their physician for further guidance.

There are several manufacturers who make “generic” Levothyroxine and Liothyronine (thyroid tablets) that your doctor can give you a new prescription for. Call the Pharmacy where you receive your Levothyroxine or Liothyronine, and ask the pharmacist who the manufacturer of their supply is. They should be able to easily tell you that.

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 you can send an email to [e-mail].

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.

To Complete and submit the report Online…....just “click” on the link & it will take you directly to the FDA MedWatch Page.

FDA Med Watch Page

If you’d like to report Adverse Reactions or quality problems by Mail or Fax: Download form

www.fda.gov/MedWatch/getforms.htm

Med Watch Reporting Form

or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form……or…….submit by

Fax to 1-800-FDA- 0178

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