THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On November 20 2012, 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 following products by Alphapharm Ltd, Royal Exchange Post Office NSW (“the Company”):
- carvedilol (DICARZ) 6.25 mg tablet blister pack [Aust R 124079]
- carvedilol (DICARZ) 12.5 mg tablet blister pack [Aust R 124081]
- carvedilol (DICARZ) 25 mg tablet blister pack [Aust R 101742]
That do not conform with paragraphs 3(2)(h) and 3(2)(i) of Therapeutic Goods Order 69 (TGO 69), in that the batch number and expiry prefixes do not precede the batch number and expiry date on the blister foil labels.
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:
- The consent applies to the foil labels of the following batches of the product only:
carvedilol (DICARZ) 6.25 mg tablet blister pack [Aust R 124079] | ||
Batch number: | Number of units: |
|
944503 | 5820 |
|
936611 | 3333 |
|
carvedilol (DICARZ) 12.5 mg tablet blister pack [Aust R 124081] | ||
Batch number: | Number of units: |
|
952462 | 7080 |
|
931898 | 5433 |
|
carvedilol (DICARZ) 25 mg tablet blister pack [Aust R 101742] | ||
Batch number: | Number of units: |
|
936587 | 13612 |
|
2. The foil labels to which this consent applies are identical to those submitted by the Company in correspondence dated November 1 2012, where the prefixes for the batch number and expiry date do not precede the actual batch number and expiry date (these prefixes are stamped on the wrong side of the foils).
3. No other changes have been made to the products:
- carvedilol (DICARZ) 6.25 mg tablet blister pack [Aust R 124079]
- carvedilol (DICARZ) 12.5 mg tablet blister pack [Aust R 124081]
- carvedilol (DICARZ) 25 mg tablet blister pack [Aust R 101742]
and the carton labels are fully compliant with TGO 69, including paragraphs 3(2)(h) and 3(2)(i).
4. A Dear Pharmacist letter setting out the above circumstances and instructing the pharmacist to advise patients to keep the blister platforms in the outer cartons until immediately before taking a dose, will be supplied with the affected batches (correspondence from the Company dated November 16 2012 refers).