Thyroid Medication Recalled After Failed FDA Inspection

By Lisa M. Schaffer, Esq. on August 20, 2018 | Last updated on March 21, 2019

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.

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."

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.

Withholding Drugs as a Weapon

Many are concerned that China will use its stronghold on the U.S. drug supply chain as a weapon against America, especially as the Trump administration's battle continues to wage with China over tariffs. Just as it is a common military strategy to starve countries into submission by limiting their food supply, some fear China could do the same with pharmaceuticals, since 80% of the pharmaceutical and over-the-counter drug ingredients are manufactured in China or India.

To date, no one has been injured by the recalled drugs. If you or your loved ones experience adverse reactions from the recalled medicines, or any medicine, contact a local drug and medical devices lawyer near you, who can listen to your situation, and advise you on how to proceed to get the best outcome.

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