Ganoderma Lucidum Complex capsule, HEC Group Pty Ltd, CON-320
Product name
Ganoderma Lucidum Complex capsule
Sponsor name
HEC Group Pty Ltd
ARTG
289420
Batches
11845
Consent start
Consent no.
CON-320
Standard
The product does not comply with the Uniformity of Weight (Mass) requirements of Appendix XII C of the British Pharmacopoeia (BP) - Subsection 10(a) of the Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules (TGO 78)
Non-compliance with standard
The product does not complybecause there is a low bulk density of fine powder
currently being used in the manufacture of the capsules. As a result the
uniformity of weight of 3 individual capsules (out of 20 capsules) was found to
be more than the acceptable BP range of +/-7.5%.
Conditions imposed
The exemption applies only to the particular batch 11845 of the product
Therapeutic product type
Over-the-counter medicines