Thyroid Medication Recalled After Failed FDA Inspection

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Westminster Pharmaceuticals has voluntarily recalled a hypothyroid medication after its Sichuan supplier’s plant failed Federal Drug Administration (FDA) inspection. The alert states that Levothyroxine and Liothronine, two synthetic hormones used in the thyroid tablets, were manufactured in a plant that the FDA warns had a number of manufacturing failures including ones related to “established standards of quality and purity.” No adverse events have been linked to the drugs to date.

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Risky Chinese Drug Supply

Just last week, the FDA recalled another drug manufactured in China, valsartan, because some batches were contaminated with NDMA, a potential cancer-causing chemical. The blood pressure drug is widely used here in the U.S., and patients had to work with their physicians and pharmacists to find an adequate substitute for this generic drug. Back in 2007 and 2008, at least 81 people died from contaminated batches of heparin, a widely used blood thinner. The Chinese factory which manufactured the drug did not have “good manufacturing practices.”

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China produces a majority of the drugs consumed here in the U.S. However, they have few product liability and consumer protection laws, and therefore the cost to distributing tainted medications are much lower than the cost to safety test. These instances highlight the challenges the FDA faces when it depends on other countries to manufacture commonly prescribed medicines. Though the FDA tests all drugs marketed here, all of these issues arose in the manufacturing process, which is strongly veiled from the FDA.

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