SHEN NENG CHING FEI YI HOU PIEN (AUSTL 57184)
Published 8 March 2016
Product
Herbal medicine Identifying features description Batch Number: 1110012
Why it was 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.
Hazard
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.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.