THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On November 19 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 product metformin hydrochloride (Glucophage) 850 mg tablet blister pack [AUST R 50469] by Alphapharm Pty Ltd, Royal Exchange PO NSW (“the Company”);
That does not conform with paragraphs 3(2)(h) and 3 (2)(i ) of Therapeutic Goods Order (TGO) 69, in that the batch number and expiry date is not preceded by the appropriate prefix 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 12462 units of batch 102064 of the product metformin hydrochloride (Glucophage) 850 mg tablet blister pack [AUST R 50469] only.
2. The foil labels to which this consent applies are identical to those submitted with the application, missing the prefixes for the batch number and expiry date, but the actual batch number and expiry date are present.
3. No other changes have been made to the product metformin hydrochloride (Glucophage) 850 mg tablet blister pack [AUST R 50469] and the carton labels are fully compliant with TGO 69, including clauses 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 carton until immediately before taking a dose, will be supplied with the affected batch (email correspondence from the Company of 16 November 2012 refers).