COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On January 10, 2014 the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to:
(a) the supply of the product chlorthalidone (HYGROTON 25) 25 mg tablet bottle [Aust R 11035],
by Link Medical Products Pty Ltd, AVALON BEACH, NSW (“the Company”);
That do not conform with paragraphs 6(1)(a) of Therapeutic Goods Order (TGO) 69, in that the product is not contained within child – resistant packaging.
Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:
- This consent applies to batch number F0004 until February 28, 2014.
- A 'Dear Healthcare Provider' letter, provided with the electronic mail dated December 20, 2013 (to A. Tan) will be supplied with the affected batch, warning that the product is not packaged in a child-resistant container and to advise patients to store the product out of reach of children.
- The Consumer Medicine Information (CMl) leaflet provided with the product is that provided with the Company letter dated December 17, 2013.
4. The above information will be broadcasted to pharmacists, advising them that each bottle of the product must be supplied with the above CMl and the consumer warning letter in addition to verbal instructions to keep the product out of reach of children.
5. No other changes have been to the product.