ALENDRONATE PLUS D3 and CALCIUM SANDOZ alendronic acid (as sodium) 70 mg and colecalciferol 140 ug tablet and calcium 500 mg tablet composite pack, Dr Reddy's Laboratories (Australia) Pty Ltd, CON-261
Product name
ALENDRONATE PLUS D3 and CALCIUM SANDOZ alendronic acid (as sodium) 70 mg and colecalciferol 140 ug tablet and calcium 500 mg tablet composite pack
Sponsor name
Dr Reddy's Laboratories (Australia) Pty Ltd
ARTG
222684
Consent start
Consent no.
CON-261
Standard
Subsection 11(b) of the Therapeutic Goods Order 78 - Standard for Tablets and Capsules (TGO 78).
Non-compliance with standard
The products do not meet the expiry assay limits of 92.5% - 107.5 % for the
stated content of colecalciferol.
Conditions imposed
The expiry colecalciferol assay limits for the products are 90.0% - 110.0%.
Therapeutic product type
Prescription medicines