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Westminster Pharmaceuticals, LLC is voluntarily recalling Levothyroxine and Liothyronine after FDA issues import alert affecting the active ingredient.
Editor's Note: The title of this article was revised on Aug. 16, 2018 to clarify that the recall applies to the combined product, Levothyroxine and Liothyronine (Thyroid Tablets, USP).
Westminster Pharmaceuticals, LLC announced on August 9, 2018 that it was voluntarily recalling all lots of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, and 120 mg to the wholesale level. The recall was initiated as a precaution after FDA placed the manufacturer of the API, Sichuan Friendly Pharmaceutical Co., Ltd., on import alert.
An FDA inspection of Sichuan Friendly Pharmaceutical Co., Ltd. performed in 2017 found deviations in current good manufacturing practices, which may pose a risk in product quality. The violations included failure to conduct residual solvent testing of API, failure to validate written procedures for equipment cleaning, failure to properly perform stability testing, and data control failures.
According to Westminster, Levothyroxine and Liothyronine (Thyroid Tablets, USP) for oral use is derived from porcine thyroid glands and contains both tetraiodothyronine sodium (T4 levothyroxine) and liothyronine sodium (T3 liothyronine). It is used to treat patients with hypothyroidism.
Westminster Pharmaceuticals, LLC stated in a press release that it had not received any reports of adverse events as of August 9. The recalled lots are packed in 100-count bottles. A complete list of recalled products can be found online.