Ostelin Specialist Range Vitamin D 7000IU, Sanofi Consumer Healthcare, CON-1306
Product name
Ostelin Specialist Range Vitamin D 7000IU
Sponsor name
Sanofi Consumer Healthcare
Batches
1656807
Consent start
Consent no.
CON-1306
Standard
Division 3 - Section 14 (1), Schedule 1, Item 1(a) “assay for each active ingredient - for active ingredients in registered goods - 90.0% - 110.0%”. of Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019
Non-compliance with standard
The product does not comply because it had a release test assay result of 6767
IU which is outside the approved release limits of 6850 -7571 IU as per approved
section 3.2.P.5.1 Finished Product Specifications.
Therapeutic product type
Registered complementary medicines