Product description
Herbal medicine
See a list of details to help identify the product
Reason the product is recalled
SHEN NENG CHING FEI YI HOU PIEN (AUSTL 57184) was found by TGA Laboratories to be contaminated with Paracetamol. The content of paracetamol was estimated by LC/MS to be 9 mcg/g (9 ppm). This is below the SUSMP threshold limit of 10 ppm (10 mg/kg) for scheduling of paracetamol. However, paracetamol is not declared in the ARTG entry for AUSTL 57184 and is not approved for use in listed medicines.
The hazards to consumers
At the maximum dose of 8 tablets a day consumers may get a 43.2mcg dose (9ppm) of Paracetamol as a result of the contamination. This may give rise to the risk of an allergic reaction following the unintended exposure to undeclared paracetamol.
What consumers should do
For further information contact: Shen Neng Herbal Medicines Group 02 9416 9831 -
Details to help identify the product
Supplier running the recall
Shen Neng Herbal Medicines Group Pty Ltd
Identifying product features
Batch Number: 1110012
Identifying numbers
Other identifying numbers
Batch Number: 1110012
Where the product was sold
Nationally
Responsible regulators
Regulators are established or appointed by government. They enforce regulations and rules.
Quote PRA number 2016/15245 when contacting a regulator about this recall.
Recall and remedy questions
Contact the Therapeutic Goods Administration if you have:
- a question about the remedy being offered to you by the business that is responsible for managing this recall, or
- concerns about the way the business is managing this recall.