COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
On October 1, 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:
- phenoxymethylpenicillin ( LPV) (as potassium) 250 mg capsule blister pack
[Aust R 66510]
- phenoxymethylpenicillin ( LPV) (as potassium) 500 mg capsule blister pack
[Aust R 66511]
By iNova Pharmaceuticals (Australia) Pty Ltd, CHATSWOOD, NSW (“the Company”);
That does not conform with paragraphs 3(2)(h) and (i) of Therapeutic Goods Order (TGO) 69, in that the batch numbers and expiry details are not preceded by the appropriate prefixes.
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 only to batches 130434, 130435, 130432, 130433 & 130780;
- No other changes have been made to the products:
- phenoxymethylpenicillin ( LPV) (as potassium) 250 mg capsule blister pack
[Aust R 66510]
- phenoxymethylpenicillin ( LPV) (as potassium) 500 mg capsule blister pack
[Aust R 66511]
3. A ‘Dear Pharmacist’ letter, provided with the Company letter dated September 30, 2013, advising healthcare practitioners to remind patients to keep the blister platforms in the correctly labelled cartons will be provided with each of the affected batches.