Westminster Pharmaceuticals has recalled all unexpired lots of levothyroxine and liothyronine (thyroid tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, and 120 mg to the wholesale level, according to a company notice posted on the US Food and Drug Administration (FDA) website.
The recall is a precautionary measure because the products were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA's import alert regarding Sichuan Friendly Pharmaceutical company in China.
The alert follows a 2017 FDA inspection that found "significant deviations" from current good manufacturing practices for active pharmaceutical ingredients that could represent the possibility of risk being introduced into the manufacturing process, the FDA said.
Thyroid contains both tetraiodothyronine sodium (T4 levothyroxine) and liothyronine sodium (T3 liothyronine) and is a natural preparation derived from porcine thyroid glands for oral use as replacement or supplemental therapy in patients with hypothyroidism.
Patients are advised to continue taking the recalled medicines until they have a replacement product.
To date, Westminster Pharmaceuticals has not received any reports of adverse events related to the products.
The recalled products are packed in 100-count bottles. National drug codes, descriptions, as well as the 38 lot numbers and expiration dates for the products are available on the FDA website.
Westminster is notifying its direct customer accounts by email and phone to immediately discontinue distribution of the recalled products and notify their subwholesale accounts of the product recall.
"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," says Gajan Mahendiran, chief executive officer of Westminster Pharmaceuticals.
Questions about the recall may be directed to the regulatory affairs department of Westminster Pharmaceuticals by phone (1-888-354-9939) or email (recalls@wprx.com). The company’s press release is available here.
Health providers are asked to report adverse events related to these products to MedWatch, the FDA safety information and adverse event reporting program.
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Cite this: Thyroid Tablets Recalled in US Because of Impurity Risk - Medscape - Aug 13, 2018.
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