COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
On November 22, 2013 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 products
- vancomycin (as hydrochloride) DBL VANCOMYCIN 1g powder for injection vial
[Aust R 62595]
- vancomycin (as hydrochloride) DBL VANCOMYCIN 500 mg powder for injection vial [Aust R 62603]
by Hospira Australia, MELBOURNE, VIC (“the Company”);
That does not conform with paragraphs 3(1)(b)(ii) of Therapeutic Goods Order (TGO) 69, in that the letter height requirement is not met by the vial labels (some text has a letter height of only 1.2 mm instead of the required letter height of at least 1.5 mm).
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 to supply applies until the end of October 2014.
- The foil labels to which this consent applies are those provided with the Company letter application.
- No other changes have been made to the foil labels, and the carton labels used are those currently approved.