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Regulatory Focus™ > News Articles > 8 > Chinese Thyroid Drug API Recalled in US Over Quality Concerns

Chinese Thyroid Drug API Recalled in US Over Quality Concerns

Posted 20 August 2018 | By Michael Mezher 

Chinese Thyroid Drug API Recalled in US Over Quality Concerns

The US Food and Drug Administration (FDA) on Friday advised drugmakers and compounders not to use porcine thyroid active pharmaceutical ingredient (API) produced by Chinese firm Sichuan Friendly Pharmaceutical over quality concerns.
"FDA laboratory testing confirmed the Sichuan Friendly API has inconsistent levels of active ingredients – levothyroxine and liothyronine – and should not be used to manufacture or compound drugs for patient use," the agency writes.
FDA also notes that it has not approved any combination levothyroxine/liothyronine products, though it has approved drugs containing either active ingredient on its own to treat hypothyroidism.
Potential risks include over- or under-treatment of hypothyroidism that could cause "permanent or life-threatening adverse health consequences," the agency says.
The firm, which is recalling all lots of the API made since 2015, was warned for good manufacturing practice (GMP) violations by FDA in June and placed on Import Alert in March.
Despite being placed on Import Alert, FDA says it has confirmed that the API remains in the US supply chain, and cautions that the API and products made from it may have been repackaged or relabeled and may not identify Sichuan Friendly as the original source of the ingredient.
"Manufacturers and compounders who make levothyroxine and liothyronine drug products should contact their API supplier to verify the actual manufacturer of the thyroid API they received before using it," FDA says.
Companies are also instructed to quarantine any of the recalled API or drug products containing it and notify their FDA regional office for further instruction.
Earlier this month, Westminster Pharmaceuticals voluntarily recalled all lots of its levothyroxine and liothyronine tablets as they were made from API sourced from Sichuan Friendly prior to the Import Alert.
Patients are advised to continue taking their medicine as prescribed until they have spoken with their doctors and are encouraged to discuss FDA-approved treatments for hypothyroidism.


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