Media releases & statements

December

Black Storm tablets

10 December 2019

Black Storm tablets pose a serious risk to your health and should not be taken
Prescription opioids hub

10 December 2019

New resources for health professionals added
EpiPen Jr

5 December 2019

Update on shortage
Kulchaya Sheaya Lender capsules

5 December 2019

Kulchaya Sheaya Lender capsules pose a serious risk to your health and should not be taken

November

Brauer Teething Gel 20 g

29 November 2019

Recall - bacterial contamination of one batch
Sheaya Herbs tablets by Kulchaya

29 November 2019

Sheaya Herbs tablets by Kulchaya pose a serious risk to your health and should not be taken
PURE BIOTHROID-B No1 Tablets

29 November 2019

PURE BIOTHROID-B No1 tablets pose a serious risk to your health and should not be taken
Breast implants and anaplastic large cell lymphoma

28 November 2019

Update - Outcomes from the TGA's review of breast implants and breast tissue expanders
Update on safety and performance concerns of suspended breast implants

28 November 2019

Further details regarding the safety and performance concerns of the breast implant devices which have been suspended has been published
TGA response to federal court decision on urogynaecological mesh class action

26 November 2019

We will closely consider the judgment including any further improvements that could enhance the regulatory system in Australia.
Acalabrutinib receives TGA approval for CLL and SLL cancers

25 November 2019

Acalabrutinib receives approval through the second international collaborative review initiative between the TGA, FDA and Health Canada
Ying Da Wang tablets

19 November 2019

Ying Da Wang tablets pose a serious risk to your health and should not be taken
Complementary medicines advertisers: 19 November 2019 update

19 November 2019

Consumer Healthcare Products Australia to handle all medicine advertising pre-approval applications
TGA joins ICMRA campaign against antimicrobial resistance

19 November 2019

The TGA has joined the ICMRA and the WHO in a coordinated global approach to fighting antimicrobial resistance
Current status of breast implant products in Australia

18 November 2019

The list of current ARTG entries for breast implants has been updated
Complementary medicines advertisers: 14 November 2019 update

14 November 2019

The Complementary Healthcare Council of Australia is no longer accepting advertising pre-approval applications
Accu-Chek Guide and Accu-Chek Performa blood glucose meters

14 November 2019

Product defect correction – risk of delayed therapy due to potential battery issues
De2Xy capsules

14 November 2019

De2Xy capsules pose a serious risk to your health and should not be taken
Impersonation of Commonwealth public officials

13 November 2019

The Therapeutic Goods Administration is aware that a member of the public has purported to be a Commonwealth public official during a recent incident in Melbourne
Me2Shape capsules

13 November 2019

Me2Shape capsules pose a serious risk to your health and should not be taken.
Beware the Barbie drug: the dangers of using melanotan

13 November 2019

The Therapeutic Goods Administration (TGA) urges consumers to steer clear of products containing 'melanotan'
Microneedling device cancelled in Australia

11 November 2019

A warning to consumers about undergoing procedures using unapproved medical devices
Grakcu capsules

6 November 2019

Grakcu capsules pose a serious risk to your health and should not be taken

October

Advertisers of complementary medicines

29 October 2019

Changes are coming in November to the advertising pre-approval arrangements for some complementary medicines advertisements
Gentamicin Injection USP 40 mg/mL (80 mg/2 mL) ampoules

25 October 2019

Safety advisory - alternative product filling shortage may cause airway irritation if administered via inhalation
Importation of e-cigarettes containing nicotine (and nicotine-containing liquids for use in e-cigarettes)

25 October 2019

Rules apply to the importation of nicotine-containing e-cigarettes
Ranitidine

22 October 2019

Update - contamination with N-nitrosodimethylamine
Tofacitinib

15 October 2019

Update - Warning about increased risks of blood clots and of death at higher dose for certain patients
Febuxostat (Adenuric) tablets

1 October 2019

Safety advisory – increased risk of death in gout patients with a history of major cardiovascular disease

September

Australian regulatory action on breast implants and breast tissue expanders

26 September 2019

The TGA has released the findings of its review into breast implants and breast tissue expanders
Slimina Weight Loss capsules

20 September 2019

Slimina Weight Loss capsules pose a serious risk to your health and should not be taken
Arthrem capsules

19 September 2019

Update to safety advisory
Ballerina Anti-Obesity capsules

18 September 2019

Ballerina Anti-Obesity capsules pose a serious risk to your health and should not be taken
Provisional application receives approval through the first international collaborative review initiative between TGA, FDA and HC

18 September 2019

International Collaborative Review Initiative gives provisional approval of lenvatinib in combination with pembrolizumab
Ranitidine

17 September 2019

Potential contamination of ranitidine with the N-nitroso compound NDMA
Redback SARMs pays fine for advertising prescription-only substances

10 September 2019

Infringement notice issued for the alleged advertising of Schedule 4 substances
PharmaCare pays $12,600 fine for alleged advertising of cancelled therapeutic good

10 September 2019

Infringement notice issued for the alleged advertising of a cancelled therapeutic good
Jin Gui Shen Qi Wan (oral pills)

5 September 2019

Recall - potential toxicity (金匮肾气丸 - statement includes Chinese translation 中文翻译)

August

Therapeutic goods advertising: update 31 July 2019

20 August 2019

Update on amendments to the Therapeutic Goods Advertising Code (No.2) 2018 and medicines advertising pre-approval
TGA cracking down on non-compliant advertising of bioresonance and similar devices

16 August 2019

The TGA has commenced work on a sector-wide compliance activity relating to the advertising of bioresonance devices
Bali Mojo capsules

9 August 2019

Bali Mojo capsules pose a serious risk to your health and should not be taken
Hong Kong Tianli Biological – power tablet

9 August 2019

Hong Kong Tianli Biological - Power tablets pose a serious risk to your health and should not be taken
Australian traveller fined for importing unapproved products in luggage

7 August 2019

An individual has been fined for the alleged importation of unapproved cosmetic products after returning from an overseas trip to China
Man fined for alleged importation and advertising of unapproved therapeutic goods

6 August 2019

Infringement notices issued for the alleged importation and advertising of unapproved performance and image enhancing products
Allergan macro-textured breast implants and tissue expanders

2 August 2019

Hazard alert – risk of breast implant-associated anaplastic large cell lymphoma in rare cases

July

Sports supplements in Australia

31 July 2019

Information on how supplements are regulated in Australia
Endone 5 mg tablets

30 July 2019

Product defect correction – potential for incorrect medicine in the pack
Improved medicines information for consumers

26 July 2019

Improvements to Consumer Medicine Information
Thermography should not be relied on for early detection of breast cancer

26 July 2019

Important information about the dangers of using thermography for breast cancer detection
$10 million penalty ordered against Peptide Clinics Pty Ltd for advertising breaches

23 July 2019

The Federal Court has imposed substantial penalties on Peptide Clinics Australia
Be alert when considering cosmetic injections

23 July 2019

Risks associated with cosmetic injections can be related to both the product and the experience of the person performing the procedure
Neutrogena Visibly Clear Light Therapy Acne Mask and Activator

17 July 2019

Recall - Potential for eye damage
State and territory governments continue to regulate fluoridated drinking water in Australia

15 July 2019

The TGA has clarified that state and territory governments will continue to regulate fluoridated drinking water in Australia
Return unused prescription opioids to your local pharmacy

11 July 2019

The TGA is urging Australians to return unused prescription pain relief medicines to their local pharmacy
TGA strengthens regulation of stem cell treatments

9 July 2019

New regulations for stem cell treatments in Australia came into force on 1 July 2019
Share your views in the 2019 TGA stakeholder survey

8 July 2019

The 2019 TGA stakeholder survey is open. Have your say before 5 July
A reminder to return your unused opioids to your local pharmacy

3 July 2019

We're encouraging all Australians to return their unused opioids to their local pharmacy
Slim Perfect Legs + High Fiber capsules

2 July 2019

Slim Perfect Legs + High Fiber capsules pose a serious risk to your health and should not be taken
GoLean Detox capsules

1 July 2019

GoLean Detox capsules pose a serious risk to your health and should not be taken
International work-sharing Initiative - Niraparib (Zejula®)

1 July 2019

International work-sharing initiative approves Niraparib (Zejula®)

June

Using 'natural' claims when advertising to the public

11 June 2019

Reasons for releasing guidance and how it was developed
The TGA seize SARMs and Nootropics during search warrants in the Sutherland Shire, NSW

4 June 2019

On Thursday 30 May 2019, the Therapeutic Goods Administration (TGA) executed four search warrants connected to a business operating in the Sutherland Shire, Sydney

May

The TGA has seized Bloodroot Salve (Black Salve) and Bloodroot Capsules during search warrant on the Gold Coast

31 May 2019

The TGA has seized black salve products after executing a search warrant at a business premises on the Gold Coast
Curam Duo 400/57

22 May 2019

Recall – potential for reduced effectiveness
Fallopia multiflora (he shou wu)

21 May 2019

Update - products recalled
Hair Tonic and Hairpro capsules

21 May 2019

Recall - risk of liver injury
TGA actions after review into urogynaecological surgical mesh implants

17 May 2019

Update to Mesh Hub notifying of recent recall actions
TGA continues action against Peptide Clinics Australia for alleged advertising breaches

17 May 2019

Court action continues against Peptide Clinics Australia for alleged advertising breaches
Fluad trivalent influenza vaccine

9 May 2019

Safety advisory - risk to patients with latex allergy
Glyceryl trinitrate tablets (Anginine and Lycinate)

2 May 2019

Update 4 - continuing medicine shortage
Metronidazole intravenous infusion 500 mg/100 mL bag

2 May 2019

Update - medicine shortage resolved
Vitex agnus-castus

2 May 2019

Safety advisory - potential for interaction with oral contraceptives

April

Weleda Baby Teething Powder 60 g

29 April 2019

Recall - ingestion of plastic fragments may pose potential choking hazard
Significant decrease in the amount of codeine supplied to Australians

24 April 2019

TGA data analysis
Double Maxx D.B.M. Capsules

18 April 2019

Double Maxx D.B.M. Capsules pose a serious risk to your health and should not be taken.
BMSW 4600MG Black Ant Capsules

17 April 2019

BMSW 4600MG Black Ant Capsules pose a serious risk to your health and should not be taken
Japan Tengsu tablets

17 April 2019

Japan Tengsu tablets pose a serious risk to your health and should not be taken
Horny Little Devil Capsules

17 April 2019

Horny Little Devil Capsules pose a serious risk to your health and should not be taken
2019 seasonal influenza vaccines

17 April 2019

Information for consumers and health professionals
Infections associated with heater-cooler devices

16 April 2019

Statement on the post-market review of heater-coolers has been updated
International Work-sharing Initiative - Abemaciclib (Verzenio)

9 April 2019

Second candidate in international work-share initiative
Lotus Flower capsules

3 April 2019

Lotus Flower capsules pose a serious risk to your health and should not be taken
Magnum XXL capsules

3 April 2019

Magnum XXL capsules pose a serious risk to your health and should not be taken
X Power 3 tablets

3 April 2019

X Power 3 tablets pose a serious risk to your health and should not be taken
JOYSMI capsules

3 April 2019

JOYSMI capsules pose a serious risk to your health and should not be taken
Meizitang Botanical soft gel capsules

3 April 2019

Meizitang Botanical soft gel capsules pose a serious risk to your health and should not be taken.
Mylanta Antacid Double Strength Oral Liquid 500 mL

1 April 2019

Product defect correction - potential for soft lumps in the liquid

March

Make Coarser Make Bigger capsules

18 March 2019

Make Coarser Make Bigger capsules pose a serious risk to your health and should not be taken.
Morphine Sulfate Injection BP 30 mg in 1 mL ampoule

5 March 2019

Safety advisory – Section 19A product not for epidural or intrathecal use
Understanding Australia's new opioid overdose rescue treatment

4 March 2019

Australian launch of a new product called Nyxoid nasal spray for opioid overdoses
Review of the Narcotic Drugs Act 1967

4 March 2019

Invitation to comment on discussion paper now published

February

'Sartan' blood pressure medicines

26 February 2019

TGA investigation - potential contamination with N -nitroso compounds
Update to the advertising complaints and investigation information database improves search features

25 February 2019

This update implements feedback from stakeholders to make the database more user-friendly
ISHOU Fulin Ruan Jiaonang capsules

25 February 2019

ISHOU Fulin Ruan Jiaonang capsules pose a serious risk to your health and should not be taken
BASCHI Quick Slimming capsules

25 February 2019

BASCHI Quick Slimming capsules pose a serious risk to your health and should not be taken
Deli by New Queen capsules

22 February 2019

Deli by New Queen capsules pose a serious risk to your health and should not be taken
Boxy Indelar capsules

18 February 2019

Boxy Indelar capsules pose a serious risk to your health and should not be taken
Mang Luk Power Slim capsules

18 February 2019

Mang Luk Power Slim capsules pose a serious risk to your health and should not be taken
Australian company pays fine for illegal medicine exports

18 February 2019

On 14 December 2018, the TGA issued an infringement notice for export of unlawful medicines from Australia
Jurnista (hydromorphone hydrochloride) prolonged-release

13 February 2019

Product defect correction - potentially damaged tablets

January

ConvaTec Australia devices

25 January 2019

Recall of multiple products - potential for breaches of sterile packaging
EpiPen 300 mcg adrenaline auto-injector

23 January 2019

Update - medicine shortage resolved
OA/RA capsules

23 January 2019

Recall due to contamination
St John Ambulance Tiny Tots First Aid Kit - electronic thermometer

21 January 2019

Recall - potential risk of harm for children who access the button battery
A warning to consumers about the serious health risks relating to e-cigarette liquid

15 January 2019

The TGA is alerting consumers to the potential risks of purchasing electronic cigarette liquid
Germany Black Ant 2000mg tablets (Zhansheng Weige Chaoyue Xilishi)

15 January 2019

These tablets pose a serious risk to your health and should not be taken
South Australian man faces criminal charges for dealing with counterfeit and unapproved medicines

4 January 2019

Dealing countefeit and unapproved medicines is a serious offence as shown in recent TGA prosecution outcome in South Australia

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