SHEN NENG RUN CHANG WAN (Shen Neng Herbal Medicines Group Pty Ltd)
In addition, manufacturing documents from the sponsor contained medicine composition information that was inconsistent with the ARTG record. These inconsistencies could affect the quality and therefore the safety of this medicine.
While the safety of this medicine was therefore considered to be unacceptable, current data indicate this medicine is unlikely to pose an immediate risk to consumer health and safety. Additionally, the sponsor stopped supply of this medicine in July 2020, and the affected batch expired on 16 December 2021.
The TGA notified the sponsor that amygdalin was detected in this medicine. The sponsor cancelled this medicine and withdrew it from further supply. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with this medicine.