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www.fdanews.com/articles/188065-westminster-recalls-two-thyroid-drugs-due-to-api-suppliers-deficiencies
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Westminster Recalls Two Thyroid Drugs Due to API Supplier’s Deficiencies

August 17, 2018

Westminster Pharmaceuticals recalled two of its thyroid drugs after manufacturing them with APIs sourced from a Chinese supplier the FDA cited for GMP violations.

Westminster said it had not received any reports of adverse events involving the products but was issuing the recall as a precaution, as substandard GMP practices could exacerbate safety risks in the manufacturing process.

The drugs — Levothyroxine and Liothyronine — were manufactured using questionable APIs from Sichuan Friendly Pharmaceutical. Westminster obtained the ingredients before the supplier was placed on an import alert following an October FDA inspection of the firm’s Neijiang City plant.

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