Supply of amoxycillin (as trihydrate) (AMOXIL) 500 mg capsule blister pack by Aspen Pharmacare Australia Pty Ltd

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

On November 28, 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 amoxycillin (as trihydrate) (AMOXIL) 500 mg capsule blister pack [Aust R 57574].

by Aspen Pharmacare Australia Pty Ltd, ST LEONARDS, NSW (“the Company”);

That do not conform with paragraphs 3(2)(c) and 3(13)(a) of Therapeutic Goods Order (TGO) 69, in that the quantity or proportion of the active ingredient is not correctly expressed.

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 to supply applies only to batch 18427K833 of the foil labels of the starter pack.
2. The foil labels to which this consent applies are those submitted with the Company application, incorrectly stating that the capsules contain 500 mg of amoxycillin trihydrate, instead of stating that they contain 500 mg of amoxycillin.
3. The Dear Doctor letter supplied with the Company letter dated November 25, 2013, setting out the circumstances surrounding this consent to supply and reminding patients to keep the blister foils with the correctly labelled cartons, will be supplied with the affected batch.