Beijing Tong Ren Tang Australia Recalls Bronchi-cough Pills (qiguanyan kesou tanchuanwan; AUST L 144659) -- Australian Recalls

Consumers and health professionals are advised that Beijing Tong Ren Tang Australia in consultation with the TGA is recalling Batch 16080020 and Batch 4080015 of Bronchi-cough Pills (qiguanyan kesou tanchuanwan; AUST L 144659) due to contamination with substances that pose an unacceptable risk to health.
TGA testing has found that both currently available batches of the product are contaminated with low levels of amygdalin. One batch (16080020) is also contaminated with very low levels of aristolochic acid. Both amygdalin and aristolochic acid are included in Schedule 10 to the Poisons Standard, which lists substances considered to pose an unacceptable risk to health.
There is no established safe exposure level to aristolochic acids, which have been linked to kidney problems and urinary tract cancers.

Information for consumers

If you or someone you provide care for takes Bronchi-cough Pills, please be alert to this issue and discontinue use immediately. The product should not be consumed.
If you have any Bronchi-cough Pills, the remaining product can be returned to the place of purchase for a refund.
If you have any questions or concerns about this issue, talk to your health professional or contact 1300 287 828.

Information for health professionals

Please be aware of the above issue and advise patients regarding alternative treatment options if they seek advice.
If you have any questions or concerns about this issue, contact 1300 287 828.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.

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支气管咳嗽丸 (气管炎咳嗽痰喘丸)

因污染召回

消费者和健康专业人士请注意，由于物质污染对健康造成不可接受的风险，北京同仁堂澳大利亚公司与澳大利亚治疗产品管理局（TGA）协商现在召回批号16080020和批号4080015的支气管咳嗽丸（气管炎咳嗽痰喘丸）。
治疗产品管理局检测发现，目前可用的两批产品都受到低水平的苦杏仁苷污染。其中一批（16080020）还受到极低浓度的马兜铃酸污染。苦杏仁苷和马兜铃酸均被列入"毒物标准"附表10。列入此附表的是被认为对健康构成不可接受风险的物质。
马兜铃酸与肾脏问题和泌尿道癌症有关，它没有确定的安全使用水平。

消费者信息

如果您或您提供护理的人服用支气管咳嗽丸，请注意此问题并立即停止使用。不应服用该产品。
如果您有任何支气管咳嗽丸，剩余产品可以退回购买地点退款。
如果您对此问题有任何疑问或疑虑，请咨询您的健康专家或联系1300 287 828。

健康专业人士信息

请注意上述问题。如果患者寻求建议，请提供其他治疗方案。
如果您对此问题有任何疑问或疑虑，请联系1300 287 828。

报告问题

治疗产品管理局鼓励消费者和健康专业人士报告药物或疫苗的问题。您的报告将有助于我们对这些产品的监控。
治疗产品管理局无法就个人健康状况提供建议。如果您担心与药物或疫苗相关的不良反应事件，建议您向健康专业人士咨询。

• Category:Alert/Advisory, Medicines safety
• Tags:recalls
• URL:https://www.tga.gov.au/node/873226