The Food and Drug Administration (FDA) has ordered the recall of two batches of a medication used to treat hypothyroidism, after stability tests found its active ingredient levels had fallen below standard, potentially reducing the drug's effectiveness, an FDA official said today.
The recall covers batches D2402370 and D2402371 of Thyrocure 50mcg, totaling more than 1.12 million tablets manufactured by Biofrontier Inc, Asia.
The medication's main active ingredient, levothyroxine sodium, is used to treat hypothyroidism, or underactive thyroid, the FDA said.
Photo taken from Food and Drug Administration package insert electronic system
FDA official Yang Po-wen (楊博文) said that the company voluntarily notified the agency on Sept. 30 after three-month stability tests showed the active ingredient content had fallen below the required specification limit, possibly reducing the drug's effectiveness.
The FDA has instructed the company to complete the recall by Nov. 3, Yang said.
A total of 1,123,000 tablets from the affected batches have been distributed, while 1,175,760 tablets remain in stock — enough for about 49 months of domestic supply, Yang added.
The company also plans to import another 500,000 tablets, or about 21 months of supply, in the first quarter of next year.
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