What is the problem?

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Following TGA laboratory testing, if the product is taken at the recommended daily dose as described on the label of 9g per day, the level of lead found in the two batches of Xinyi Biyan Pills is above the Permitted Daily Exposure (PDE) for lead of 5 micrograms.

The acceptable PDE is outlined in the Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019.

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What are the risks?

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Exposure to high levels of lead can result in a range of adverse effects depending on how much lead has been consumed and for how long. This can include high blood lead levels with no obvious symptoms or potentially lead to lead poisoning after higher or longer exposure. Pregnant women and children are at a greater level of risk from lead poisoning.

If you have taken the medicine and are concerned that you may have been exposed to increased levels of lead, you should seek medical advice from your medical practitioner.

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What should I do?

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Do not use bottles of Xinyi Biyan Pills with batch numbers: DB0014M and DB0015M and with expiry Date(s): 11/12/2027. Return it to the place of purchase for a refund or call Well Herb customer service to arrange the return of affected product and a refund.

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Further information

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Please contact Well Herb customer service on 02 97237832 for further information.

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Reporting problems

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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.

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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.