PRA number
2016/15245
Published date
Product description
Herbal medicine
Reasons 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 -
Supplier
Shen Neng Herbal Medicines Group Pty Ltd
Where the product was sold
Nationally
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.