COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 18 December 2015, a delegate of the Secretary of the Department of Health, on the application of Johnson & Johnson Pacific Pty Limited, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of
• BENADRYL DRY, TICKLY COUGH oral liquid (AUST R 174281), batches 571717, 584443 and 489255
that do not conform with the requirements of the Therapeutic Goods Order No. 77 Microbiological Standards for medicines. The product does not meet the preservative efficacy requirements for A. brasiliensis specified in the British Pharmacopoeia, Appendix XVIC. Efficacy of Antimicrobial Preservation or the European Pharmacopoeia, Efficacy of Antimicrobial Preservation (5.1.3).
The consent is effective from 18 December 2015 until 30 September 2017 and applies to batches 571717, 584443 and 489255 only.
The consent is subject to the following condition:
- The efficacy of antimicrobial preservation of the medicines against A. niger must meet the requirements specified in the United States Pharmacopoeia – National Formulary Chapter <51> Antimicrobial Effectiveness Testing.