THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On July 2, 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 ciprofloxacin (DBL CIPROFLOXACIN) 200 mg / 100 mL injection for intravenous infusion bag [Aust R 123041], by Hospira Australia Pty Ltd, Melbourne, VIC (“the Company”);
That does not conform with paragraphs 3(2)(l) of Therapeutic Goods Order (TGO) 69, in that the labels state the former sponsors address instead of the current sponsor address.
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 only to batch numbers M13-1001A, M13-1001B and M13-1001C.
- The label used is that provided with the letter of application, having the old sponsor details.
- No other changes have been made to the product ciprofloxacin (DBL CIPROFLOXACIN) 200 mg / 100 mL injection for intravenous infusion bag [Aust R 123041].
4. Arrangements are in place to promptly redirect all written queries and complaints about the product sent to the old address to the current address.