争议事件
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2026
食藥署因雜質問題下令回收心臟藥品「必克樂」膜衣錠
宣布召回
衛生福利部食品藥物管理署下令回收由安成藥業供應、批號BCLA91的「必克樂」膜衣錠5毫克共58.6萬顆。此令源於供應商通報,近期安定性試驗中雜質含量已達規格上限,可能影響藥品品質與療效。該公司被要求在8月31日前完成回收,並提交回收報告及矯正預防措施。
卫生福利部食品药物管理署下令回收由安成药业供应、批号BCLA91的「必克乐」膜衣锭5毫克共58.6万颗,原因是供应商通报近期安定性试验中杂质含量已达规格上限,可能影响药品品质与疗效。该公司被要求在8月31日前完成回收,并提交回收报告及矫正预防措施。
品牌回应
召回 — Anxo Pharmaceutical Co.
The recall of Biocor Film-Coated Tablets 5 mg, supplied by Anxo Pharmaceutical Co. and bearing batch number BCLA91, was announced by the TFDA on Wednesday.
来源摘录
The Taiwan Food and Drug Administration (TFDA) has ordered the recall of 586,000 tablets of a heart medication because of impurities that could potentially affect its efficacy.
Liu said the company was ordered to complete the recall by Aug. 31 and submit a recall report, along with corrective and preventive measures to avoid similar problems in the future.
The recall of Biocor Film-Coated Tablets 5 mg, supplied by Anxo Pharmaceutical Co. and bearing batch number BCLA91, was announced by the TFDA on Wednesday.