Supply of irbesartan/hydrochorothiazide 300mg/12.5 mg (KSART HCT 300/12.5) tablet blister pack by Spirit Pharmaceuticals Pty Ltd

THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

On February 28 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 irbesartan/hydrochorothiazide 300 mg/12.5 mg (KSART HCT 300/12.5) tablet blister pack [AUST R 186254], by Spirit Pharmaceuticals Pty Ltd, The Rocks, NSW (“the Company”);

That does not conform with paragraph 3(2)(i) of Therapeutic Goods Order (TGO) 69, in that the expiry date is not preceded by the appropriate prefix on the blister foils.

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:

1. The consent applies to batch number 005 only.
2. No other changes have been made to the product irbesartan/hydrochorothiazide 300 mg/12.5 mg (KSART HCT 300/12.5) tablet blister pack [AUST R 186254].
3. The foil label is identical to those provided with the letter from the Company dated January 25 2013; the expiry date prefix is missing, but the expiry date is still present.
4. A ‘Dear Pharmacist’ letter, provided with the email from the Company dated February 26 2013, reminding patients to keep the blister strips within the carton, will be supplied with the affected batch.