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🇹🇼 Taiwan /Health & Science

Taiwan Recalls 586,000 Blood Pressure Pills Due to Impurity Concerns

From Liberty Times · () Chinese

Translated from Chinese and summarized by DistantNews. Read the original for the full story.

At a glance

News Named sources Outcome reported
  • Taiwan's FDA is recalling 586,000 tablets of the blood pressure medication 'Beken Film-Coated Tablets 5mg' due to impurity concerns.
  • The recall was initiated by the manufacturer, Ying Yuan Biotech Pharmaceutical, after stability tests showed impurity levels reached the specification limit.
  • While the recall affects a significant quantity, the FDA stated there is no immediate concern of drug shortage as over 10 alternative medications with the same ingredients are available.

Taiwan's health authorities have ordered the recall of nearly 600,000 tablets of a popular blood pressure and heart medication. The 'Beken Film-Coated Tablets 5mg,' produced by Ying Yuan Biotech Pharmaceutical Co., Ltd., are being removed from circulation after stability tests revealed impurity levels had reached the upper limit of acceptable specifications.

The impurity content has reached the upper limit of the inspection specification.

— Liu JiapingLiu Jiaping, a chief technical specialist at the FDA's Drug Administration Division, explaining the reason for the recall.

The recall, affecting one batch (BCLA91), was proactively reported by the manufacturer. The drug is prescribed for high blood pressure, angina, and stable chronic heart failure. The potential impact on drug quality and the stability of its therapeutic effect prompted the immediate recall action.

Considering the potential impact on drug quality and the stability of its therapeutic effect, a recall was initiated.

— Liu JiapingLiu Jiaping, a chief technical specialist at the FDA's Drug Administration Division, explaining the reason for the recall.

According to the Food and Drug Administration (FDA), the recalled quantity amounts to 586,000 tablets. This figure represents a substantial portion, approximately 78%, of the medication's usage under Taiwan's National Health Insurance program last year, which totaled over 750,000 tablets. Despite the large recall, the FDA assured the public that there is no immediate risk of a drug shortage. Over ten other pharmaceutical companies hold licenses for medications with identical active ingredients, dosages, and formulations, providing ample alternatives for patients.

There is currently no concern of a drug shortage.

— Liu JiapingLiu Jiaping, a chief technical specialist at the FDA's Drug Administration Division, assuring the public about alternative medications.

The FDA urged patients with chronic conditions not to discontinue their medication independently. Those holding the recalled batch are advised to consult their prescribing physician or dispensing pharmacy for professional guidance on managing their treatment. Ying Yuan Biotech Pharmaceutical has been instructed to complete the recall by August 31 and submit an investigation report along with preventive measures. Failure to comply could result in fines ranging from NT$200,000 to NT$5 million.

Chronic disease patients should not stop taking medication on their own due to the drug recall.

— FDAThe FDA's reminder to patients regarding the medication recall.
About this summary

Originally published by Liberty Times in Chinese. Translated, summarized, and contextualized automatically by DistantNews, with a note on how the source frames the story. Not individually reviewed before publishing. How this works.

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