COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 27 August 2014, 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”), on the application of Pharmacare Laboratories Pty Ltd, gave consent to:
- the supply of Pharmacist Ibuprofen Suspension for Children 200mL bottle [AUST R 92686] that does not conform with the requirements of the British Pharmacopoeia monograph for Ibuprofen Oral Suspension, in that the amount of ibuprofen in the medicine (105.5% of the label claim) is outside the limit specified in the British Pharmacopoeia (95.0 to 105.0% of the stated amount).
The consent is effective from 27 August 2014.
The consent applies to batches B14D116 and B14D117 only.