Supply of Hydralazine Hydrochloride (Apresoline) 20 mg powder for injection ampoule by Link Medical Products Pty Ltd

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

On September 25, 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 product  hydralazine hydrochloride (APRESOLINE) 20 mg powder for injection ampoule [Aust R 43190]

 by Link Medical Products Pty Ltd, WARRIEWOOD, NSW (“the Company”);

That do not conform with paragraphs 3(2)(g), (j) & 3(11)(c) of Therapeutic Goods Order 69, in that the ampoule label does not contain the batch number prefix and the Australian sponsor’s details. The carton labels do not include; the appropriate warning statement(s), the correct storage conditions and, the Australian Approved Name for glucose.

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. This consent applies only to batch number 132005;
2. The cartons will be over-stickered with the AUST R number and the Australian sponsor’s details;
3. A ‘Dear Pharmacist’ letter, provided with the email dated September 24, 2013, advising healthcare practitioners to disregard the stated storage temperature on the carton and to disregard the carton leaflet will be provided with each order of the affected batch;
4. A copy of the Australian approved Product Information document will accompany each             ‘Dear Pharmacist’ letter; and
5. No other changes have been made to the product, hydralazine hydrochloride (APRESOLINE) 20mg powder for injection ampoule [Aust R 43190].