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MN084  FDA Issues Recall of Levothyroxine (Thyroid Tablets)

MN084 FDA Issues Recall of Levothyroxine (Thyroid Tablets)

FromMedicare Nation


MN084 FDA Issues Recall of Levothyroxine (Thyroid Tablets)

FromMedicare Nation

ratings:
Length:
19 minutes
Released:
Aug 24, 2018
Format:
Podcast episode

Description

Hey Medicare Nation! I have a special show for you today. 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 Le
Released:
Aug 24, 2018
Format:
Podcast episode

Titles in the series (100)

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