THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On May 20 2013 the delegate of the Secretary of the Department of Health and Ageing 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 zinc chloride (ZINC CHLORIDE) 10.6 mg/2 mL injection vial [Aust R 22876], by Phebra Pty Ltd , Hunters Hill, NSW (“the Company”);
That does not conform with the United States Pharmacopoeia (USP) 36 monograph for Zinc Chloride Injections in that the pH of the product is not in the range of 1.5-2.5 as described.
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:
- The consent applies until May 31 2015.
- The pH of the injection is 3.0-5.0.
3. The Company will take appropriate regulatory action to reformulate the product and update the finished product specifications to ensure compliance with the USP monograph for Zinc Chloride Injections.
4. No other changes have been made to the product, zinc chloride (ZINC CHLORIDE) 10.6 mg/2 mL injection vial [Aust R 22876].