Shen Neng Ching Fei Yi Hou Pien
Notice Date
Product Description
Product description
Herbal medicine - Shen Neng Ching Fei Yi Hou Pien
Identifying features
Batch Number: 1110012
What are the defects?
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.
What are the hazards?
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.
Where the product was sold
Nationally
What should consumers do?
For further information contact: Shen Neng Herbal Medicines Group 02 9416 9831
PRA number: 2016/15245