Niuhuang Jiedu tablets, high strength - bottle of 60

Recall - risk of adverse events due to unacceptably high level of arsenic

18 May 2015

diagram showing the box and bottle of Niuhuang Jiedu tabletsConsumers and health professionals are advised that Well Herb, in consultation with the TGA, is recalling a batch of High Strength Niuhuang Jiedu tablets (bottle of 60) because it has been found to contain arsenic at an unacceptably high level.

The affected batch, which represents all the product currently in the Australian market, is batch number SJ1220 - expiry date December 2017.

High Strength Niuhuang Jiedu tablets are a complementary medicine marketed for the treatment of symptoms of sore throat, mouth ulcers, cough, cold sores, sore gums, watery or itchy eyes, and constipation.

TGA testing has identified that High Strength Niuhuang Jiedu tablets from the affected batch contain an unacceptably high level of arsenic. The amount of arsenic found in the product may create a risk of serious illness, particularly with continuous long-term use. Symptoms of arsenic toxicity include vomiting and diarrhoea, and in more severe cases fever, skin rash, cardiac arrhythmia and kidney failure.

Information for consumers

Well Herb has written to distributors to provide instructions to remove all High Strength Niuhuang Jiedu tablets (bottle of 60) currently in stock from their shelves.

If you have this product, do not take the tablets. Taking these tablets could create a risk of serious illness.

Return the product to the place of purchase for a refund. Alternatively, you can phone Well Herb on 02 9723 7832 to arrange return of the product and a refund.

If you or someone you care for has taken High Strength Niuhuang Jiedu tablets and you have any questions or concerns about this issue, contact your health professional.

Information for health professionals

Please be aware of the above issue and advise patients accordingly if they seek advice.

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.