⚠️Medicine shortage update - Bicillin L-A prefilled syringe for injection⚠️

We have approved the importation and supply of a second overseas-registered product, Extencilline benzathine benzylpenicillin 1.2 million unit vial, until 30 September 2024: tga.gov.au/safety/shortag…

⚠️Product defect alert – A40/30 BiPAP Series⚠️

Philips is advising of interruptions and/or loss of therapy with the potential for unexpected shut down of the A30 and A40 series BiPAP devices due to a Ventilation Inoperative Alarm.

Read more: tga.gov.au/safety/recall-…

TGA officers executed a search warrant on a Sydney residence linked to an individual suspected of being involved in the manufacture and sale of compounded semaglutide on 27 March 2024.

Read more: tga.gov.au/news/media-rel…

⚠️Hazard alert - Hintermann Series H3 Total Ankle Replacement System⚠️

Allegra Innovations Pty Ltd is alerting patients, caregivers, and health care providers about a higher-than-expected risk of device failure with the Hintermann Series H3 TAR system: tga.gov.au/safety/recall-…

⚠️Product Defect Correction - Fanttest COVID-19 / Influenza A&B Antigen Test Kit⚠️

Companies supplying these test kits were made aware of the potential variability in the way the control line appears (weak/faint/pale) when positive results are obtained: tga.gov.au/safety/recall-…

We have tested a product, labelled ‘Semaglutide 2.64mg/mL, L-carnitine 100mg/mL B12 .05mg/mL solution for SC injection 3’, and found that the vials contain different amounts of vitamin B12 (cyanocablamin) and L-carnatine than what is labelled.

Read more: tga.gov.au/news/safety-al…

See the latest compliance review results for 23 listed medicines, including sunscreens, products containing caffeine and HICC; and products making claims about ADHD, anxiety, arthritis, diabetes, and pregnancy. 👉 tga.gov.au/resources/list…

⚠️Recall - Clear the Skin Formula a.k.a. Liang Xue Xiao Feng San CM116⚠️

Sun Herbal Pty Ltd is recalling one batch of this product as the label does not display the required warning statement ‘Do not use if pregnant or likely to become pregnant’. tga.gov.au/safety/product…

The Hon Mark Butler MP introduced the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 in Parliament today.

The Bill aims to reduce the widespread availability of vapes by controlling all levels of supply chains.

Read more: tga.gov.au/news/media-rel…

⚠️Updated warnings of faricimab (Vabysmo) retinal vasculitis risk⚠️

Health professionals should be alert to the warnings and inform patients/carers of the potential retinal vasculitis and/or retinal occlusive vasculitis risk associated with faricimab: tga.gov.au/news/safety-up…

⚠️Medicine shortage update – Shortages of Estradot transdermal patches to continue⚠️

Sandoz Pty Ltd has notified us that due to the manufacturing issues, the shortages of all strengths of Estradot estadiol transdermal patches have been extended: tga.gov.au/about-HRT-shor…

We have issued 5 infringement notices in the amount of $82,500 to the NSW based company Caruso’s Natural Health Pty Ltd, for an alleged failure to hold information or evidence to support 5 therapeutic uses in relation to 3 medicines.

Read more: tga.gov.au/news/media-rel…

⚠️Medicine shortage update – Vyvanse capsules⚠️

Takeda Pharmaceuticals Australia has notified us that the shortage of Vyvanse 50 mg capsules has resolved, and the shortage of Vyvanse 30 mg has been extended until 31 March 2024 due to manufacturing issues: tga.gov.au/safety/shortag…

We’re working on a range of transformative changes to make it simpler and easier for you to do business with us.

Check in regularly to stay informed about the updates and changes on our website 👉 odc.gov.au/news-media/new…

We have updated our guidance on advertising cosmetic injectables to ensure advertising rules are applied consistently across all industries that deal with therapeutic goods.

Read more: tga.gov.au/news/media-rel…

Therapeutic goods and records have been seized from a pharmacy in South Yarra, Melbourne, as part of an ongoing investigation into the alleged unlawful manufacture, supply and export of therapeutic goods including prescription only medication.

Read more: tga.gov.au/news/media-rel…

⚠️Medicine shortage update - Substitution approved for gliclazide 30 mg tablet shortages⚠️

We have made a Serious Scarcity Substitution Instrument (SSSI) that allows pharmacists to give a patient 60 mg tablets instead of the prescribed 30 mg tablets: tga.gov.au/safety/shortag…

⚠️Medicine shortage update – Transfer of Ordine (morphine) oral liquid products to Arrotex⚠️

Arrotex Pharmaceuticals has announced that it is taking over the sponsorship of the Ordine (morphine) oral liquid products.

Visit our website for more: tga.gov.au/safety/shortag…

We have issued 2 infringement notices totalling $37,560 to Queensland-based company Akula Foods Pty Ltd for the alleged unlawful import of unregistered complementary medicines.

Read more: tga.gov.au/news/media-rel…

We have issued 4 infringement notices totalling $75,120 to Liquefy Health Pty Ltd for the alleged unlawful importation and advertising of 2 unapproved complementary medicines.

Read more: tga.gov.au/news/media-rel…