THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On November 29 2012, 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 cephalexin (IBILEX 500) 500 mg capsules blister pack [Aust R 73525] by Alphapharm Pty Ltd, Royal Exchange Post Office NSW (“the Company”):
That does not conform with the requirements of paragraph 3(2)(h) of Therapeutic Goods Order 69, in that the batch number prefix is absent from the blister foil labels.
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 the foil labels of the following batches only:
Batch Number: | Number of Units: |
0051D2 | 3599 |
0052D2 | 12682 |
0053D2 | 12595 |
0054D2 | 12368 |
0055D2 | 9240 |
0056D2 | 12705 |
0057D2 | 12639 |
0058D2 | 12575 |
0059D2 | 12746 |
2. The foil labels to which this consent applies are identical to those submitted by the Company in correspondence dated November 14 2012, missing the prefix for the batch number, but the actual batch number is present.
3. No other changes have been made to the product cephalexin (IBILEX 500) 500 mg capsules [Aust R 73525].
4. A Dear Pharmacist letter, setting out the above circumstances and instructing the pharmacist to advice patients to keep the blister platforms in the outer carton until immediately before taking a dose, will be supplied with the affected batches (email correspondence from the Company dated November 16 refers).