TGA media releases and statements 2018

December

Bronchi-cough Pills (qiguanyan kesou tanchuanwan)

21 December 2018

Recall due to contamination (statement includes Chinese translation 中文翻译)
TGA statement on Allergan breast implant withdrawal in Europe

21 December 2018

Allergan has withdrawn textured breast implants in Europe
TGA operations over the holiday period 2018-19

20 December 2018

The TGA will have limited operations from Monday 24 December 2018 until Wednesday 2 January 2018
Beefit capsules

19 December 2018

Beefit capsules pose a serious risk to your health and should not be taken.
Ventilators

18 December 2018

Expert working group was held to provide recommendations on acute care ventilator post-market review
Dilart and Dilart HCT (valsartan)

18 December 2018

Update - potential alternative product recalled
APO-Valsartan (valsartan) tablets

18 December 2018

Recall - potential contamination
Duodenoscope reprocessing

18 December 2018

Update - interim results from FDA surveillance studies
Review of the Narcotic Drugs Act 1967

14 December 2018

Professor John McMillan AO appointed to review and report on the operation of the Narcotic Drugs Act 1967
TGA action against Peptide Clinics Pty Ltd for alleged advertising breaches

14 December 2018

This legal action follows an investigation by the Therapeutic Goods Administration
Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

12 December 2018

Update - medicine shortage resolved and product now available
THAN YOU tablets

11 December 2018

THAN YOU tablets pose a serious risk to your health and should not be taken.

November

Further public consultation on appropriate access and safety controls (Poisons Standard schedule) for alkyl nitrites

22 November 2018

There will not be a decision announced on scheduling of alkyl nitrites on 29 November 2018. Further public consultation will be undertaken.
SQ-RX Model 1010 Pulse Generator – used with Boston Scientific S-ICDs

8 November 2018

Hazard alert – potential battery issue
Puritan Bennett 980 Series Ventilator

1 November 2018

Update to information

October

Therapeutic goods advertising: Update 31 October 2018

31 October 2018

The 2018 Code No.2 made today replaces the code that was made on 29 June 2018, and will take effect on 1 January 2019
Chapter Plus+ By Backslim Capsules

31 October 2018

Chapter Plus+ By Backslim Capsules pose a serious risk to your health and should not be taken
Li Da Weight Loss Capsules

31 October 2018

Li Da Weight Loss Capsules pose a serious risk to your health and should not be taken
Sherb Detox capsules

30 October 2018

Sherb Detox capsules pose a serious risk to your health and should not be taken
You Slim'xs capsules

30 October 2018

You Slim'xs capsules pose a serious risk to your health and should not be taken
Mutant YK-11 Capsules

29 October 2018

Mutant YK-11 Capsules pose a serious risk to your health and should not be taken
Big Penis U.S.A tablets

29 October 2018

Big Penis U.S.A tablets pose a serious risk to your health and should not be taken
BFB Be Fast Block Capsules

29 October 2018

BFB Be Fast Block Capsules pose a serious risk to your health and should not be taken
Lanky Genuine capsules

29 October 2018

Lanky Genuine capsules pose a serious risk to your health and should not be taken
International agencies crackdown on fake medicines

24 October 2018

Joint media release between Australian Border Force and Therapeutic Goods Administration
Infections associated with heater-cooler devices

18 October 2018

TGA web statment on the post-market review of heater-coolers has been updated
Clomifene / clomiphene

8 October 2018

Update 3 - continuing medicine shortage
Glyceryl trinitrate tablets (Anginine and Lycinate)

8 October 2018

Update 3 - continuing medicine shortage
Inhaled or injected general anaesthetic agents and sedative medicines

3 October 2018

Safety advisory – possible effects on brain development in young children

September

NET Remedies homeopathic products

23 September 2018

Recall - possible microbial contamination
New web hub connects consumers and health professionals with transvaginal mesh information

19 September 2018

The TGA has launched a web hub to help consumers and health professionals find information on transvaginal (urogynaecological) surgical …
TGA Facebook has officially launched

3 September 2018

Today we celebrate the official launch of the TGA Facebook page

August

Liangzern Dietary Supplements

22 August 2018

Liangzern Dietary Supplements pose a serious risk to your health and should not be taken
Germany Niubian tablets

22 August 2018

Germany Niubian tablets pose a serious risk to your health and should not be taken
Rhino 8 Platinum 8000 capsules

22 August 2018

Rhino 8 Platinum 8000 capsules pose a serious risk to your health and should not be taken
G Female Oral Tablets

15 August 2018

G Female Oral Tablets pose a serious risk to your health and should not be taken
Essure contraceptive device

13 August 2018

Update to Essure web statement.
EpiPen 300 mcg adrenaline auto-injector

6 August 2018

Update - continuing constrained supply
Fairy capsules

2 August 2018

Fairy capsules pose a serious risk to your health and should not be taken.
Durex Real Feel condoms, 6 pack

1 August 2018

Recall - single batch does not pass shelf life durability tests

July

Share your thoughts with us in the 2018 TGA surveys

20 July 2018

Our annual survey measures satisfaction with a range of services and activities including our role and performance
Sodium glucose co-transporter 2 inhibitors

18 July 2018

Safety advisory - diabetic ketoacidosis and surgical procedures
Intragastric balloon systems

18 July 2018

Safety information for intragastric balloon systems
Montelukast

12 July 2018

Safety review
International work-sharing pilot - Apalutamide (Erlyand)

5 July 2018

Apalutamide (Erlyand) is the first medicine approved via ACSS Consortium’s NCE working group
Launch of new advertising hub and online complaints form

2 July 2018

Consumers can now report dodgy ads for medicines and medical devices through a single online form

June

Need for Seal tablets

28 June 2018

Need for Seal tablets pose a serious risk to your health and should not be taken
Gold Maka tablets

28 June 2018

Gold Maka tablets pose a serious risk to your health and should not be taken
One Night Lover tablets

28 June 2018

One Night Lover tablets pose a serious risk to your health and should not be taken
Metronidazole intravenous infusion 500 mg/100 mL bag

22 June 2018

Shortage and alternative supply of Metronidazole intravenous infusion 500 mg/100 mL bag
Platinum - Male Enhancer capsules

19 June 2018

Platinum - Male Enhancer capsules pose a serious risk to your health and should not be taken.
Bulbao Male Enhancer tablets

19 June 2018

Bulbao Male Enhancer tablets pose a serious risk to your health and should not be taken
Meltz – Instant Energy For Males tablets

19 June 2018

Meltz Instant Energy For Males tablets pose a serious risk to your health and should not be taken.
Abbott Medical ICDs and CRT-Ds

7 June 2018

Hazard alert - firmware update to improve battery performance and cybersecurity
Camellia sinensis (green tea) extract

5 June 2018

Safety advisory - potential risk of harm to the liver
Valpam 5 (diazepam) 5 mg tablets

5 June 2018

Product defect alert - potential for blister strip to contain lower strength tablets
Solve Botanical Slimming capsules

2 June 2018

Safety advisory

May

Dolutegravir

31 May 2018

Safety advisory - new study suggests possible risk of birth defects
LFIT Anatomic CoCr V40 Femoral Heads

31 May 2018

Hazard alert - potential for components to separate
Hypnotic poisom capsules

23 May 2018

Hypnotic poisom capsules safety advisory
JAGUAR 30000 capsules

17 May 2018

Safety advisory
Lishou Strong Slimming capsule

14 May 2018

Safety advisory
SLIM BODY Advanced capsules

9 May 2018

Safety advisory

April

Fluad trivalent influenza vaccine

19 April 2018

Safety advisory - risk to patients with latex allergy
ViaGro 500mg Male Enhancement capsules

18 April 2018

Safety advisory
Gold Viagra 9800mg capsules

17 April 2018

Safety advisory
LIPRO Dietary capsules

17 April 2018

Safety advisory
Stree Overlord Strong tablets (pills)

10 April 2018

Safety alert - stree overlord tablets pose a serious risk to your health and should not be taken
Vegetal Vigra capsules

9 April 2018

Safety advisory
Black Ant King tablets

9 April 2018

Safety advisory

March

2018 seasonal influenza vaccines

27 March 2018

Information about influenza vaccines for use in 2018
Flu vaccine: 2018 seasonal influenza vaccines for use in children

27 March 2018

Information about influenza vaccines for use in 2018
Slim Trim Gold capsules

27 March 2018

Slim Trim Gold capsules pose a serious risk to your health and should not be taken
Lida (Plus) capsules

27 March 2018

Lida (Plus) capsules pose a serious risk to your health and should not be taken
The TGA statement in relation to ABC’s Fact Check article on deaths from OTC codeine

25 March 2018

In reference to the ABC’s Fact Check article “Will the move to make codeine prescription-only save a 100 lives a year” the Therapeutic Goods Administration (TGA) would like to clarify:
Nutra Organics Green Tea Extract capsules

20 March 2018

Safety alert- Nutra Organics Green Tea Extract capsules
Arthrem capsules

19 March 2018

Safety advisory – potential risk of harm to the liver
Duro-K 600 mg potassium chloride tablets

15 March 2018

Advisory – lead content may exceed regulatory guidelines
Zinbryta (daclizumab)

15 March 2018

Product withdrawn after overseas reports of inflammatory brain disorders
Rite Aid Mini Digital Temple Touch Thermometer

8 March 2018

Recall - potential risk of harm for children who access the button battery
Puritan Bennett 980 Series Ventilator

8 March 2018

New suspension - Medtronic Puritan Bennett 980 Series Ventilator
Ja Dera Max+ capsules

7 March 2018

Ja Dera Max+ capsules pose a serious risk to your health and should not be taken

February

Help 100% & Pure Natural & Body Slim capsules

28 February 2018

Help 100% & Pure Natural & Body Slim Capsules pose a serious risk to your health and should not be taken
Therakos Cellex Photopheresis System

27 February 2018

Update: Therakos Cellex Photopheresis System Safety advisory – risk of blood clots
Perfect slim capsules by Peenuch

6 February 2018

Perfect slim capsules contain the undeclared substance sibutramine.

January

The story today that suggests GPs may not be able to prescribe high dose opioids under a review being done by the TGA is totally incorrect

27 January 2018

The medicines’ regulator is not proposing and will not be stopping GPs from prescribing high dose opioids
TGA opens consultation on the use of prescription opioids for pain

21 January 2018

The TGA has issued a discussion paper on the use and misuse of prescription strong opioids, such as oxycodone, and whether there is a need for specific regulatory responses
APO-Metformin XR 1000 mg tablets

19 January 2018

Recall - risk of injury due to potential contamination with plastic fragment
TGA actions after review into urogynaecological surgical mesh implants

17 January 2018

Update - Stress Urinary Incontinence (SUI) mid-urethral slings
Yunnan Feng Shi Ling capsules – counterfeit

16 January 2018

Yunnan Feng Shi Ling capsules contain the undeclared substance paracetamol.

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TGA media releases and statements 2018

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