THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On December 21 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 product nifedipine (ADALAT OROS 60) 60 mg controlled release tablet blister pack [Aust R 76040] by Bayer Australia Ltd, Pymble NSW (“the Company”):
That does 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 date prefixes are absent from 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:
Batch number | Number of Units | Expiry Date |
CR 08287 | 17994 | Jun 2015 |
CR 08237 | 17027 | Jun 2015 |
CR 08660 | 17159 | May 2015 |
CR 05916 | 7845 | May 2014 |
CR 08662 | 5887 | May 2015 |
CR 05915 | 5759 | May 2014 |
CR 08619 | 16759 | May 2015 |
2. The foil labels to which this consent applies are identical to those submitted by the Company in correspondence dated December 5 2012, missing the prefixes for the batch number and the expiry date, but the actual batch number and expiry date are present.
3. No other changes have been made to the product nifedipine (ADALAT OROS 60) 60 mg controlled release tablet blister pack [Aust R 76040], 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, will be supplied with the affected batches (correspondence from the Company dated December 21 2012 refers).