Supply of carvedilol (DICARZ) 12.5mg tablet blister pack by Alphapharm Pty Ltd Royal Exchange

COMMONWEALTH OF AUSTRALIA

Department of Health and Ageing
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On August 6, 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 carvedilol (DICARZ) 12.5 mg tablet blister pack [Aust R 124081], by Alphapharm Pty Ltd Royal Exchange PO, NSW (“the Company”);

That do not conform with paragraphs 3(2) (h) and (i) of Therapeutic Goods Order (TGO) 69, in that the blister platform does not contain the batch number and expiry 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:

1. The consent applies to batch number 959376 only.
2. A ‘Dear Pharmacist’ letter, provided with the Company letter dated August 2, 2013, will be provided reminding patients to keep the blister platforms in the carton until use.
3. No other changes have been made to the product; carvedilol (DICARZ) 12.5 mg tablet blister pack [Aust R 124081].