Media releases & statements

September

LFIT Anatomic CoCr V40 femoral heads (used in hip replacements)

27 September 2016

Hazard alert – risk of adverse events due to potential taper lock failures
Breast implants: Update on TGA monitoring of anaplastic large cell lymphoma

27 September 2016

Safety advisory
Metagenics NasoClear

27 September 2016

Recall - potential bacterial contamination
Wolfish Shark Viagra tablets

20 September 2016

Safety advisory
Rehab Assist C-Series ceiling hoists

20 September 2016

Recall for product correction - potential for attachment swivel to break
Accu-Chek Connect Diabetes Management app

12 September 2016

Safety advisory - update app to correct programming error
Tandem Bipolar Hip System

12 September 2016

Hazard alert - potential need for revision surgery due to parts becoming detached
GlucaGen HypoKit

8 September 2016

Recall - risk of needles becoming detached from syringes
Comfort impregnated cloth topical skin products

8 September 2016

Recall - potential for bacterial contamination
APO-Cabergoline 500 mcg tablets

2 September 2016

Recall - potential for degradation due to moisture
HeartWare Ventricular Assist Device

1 September 2016

Hazard alert - potential for electrical fault

August

Metformin extended release tablets

31 August 2016

Update 2 - medicine shortages change in status
General process for amending the Poisons Standard: Cannabis and Tetrahydrocannabinols

31 August 2016

The scheduling changes will be implemented in the November 2016 Poisons Standard
Warning about weight loss products on the web

30 August 2016

Media release: The dangers of buying weight loss medicines online, particularly from unknown overseas websites
Molift Air ceiling hoist

29 August 2016

Recall for product correction - potential risk of injury due to bolt coming loose
Medela breastpumps detachable wall plug for AC power adapter

26 August 2016

Recall - risk of electric shock due to breakage
Flocare Infinity enteral feeding pumps

23 August 2016

Recall for product correction - potential 'air in line' alarm issues
Astral 100 and Astral 150 ventilators

22 August 2016

Recall for product correction - risk of loss of therapy due to internal battery issue
Ant Power tablets

10 August 2016

Safety advisory
Man King capsules

10 August 2016

Safety advisory
Sponsor transfer and change of sponsor name amendments

9 August 2016

Amendments to 'sponsorship transfer' and 'changes in sponsor name' provisions will commence on 17 Aug
Alere INRatio PT/INR monitor system

5 August 2016

Update 2 - Recall details
General process for amending the Poisons Standard: Nicotine

4 August 2016

The public is invited to provide submissions on the proposed amendment to the Poisons Standard regarding nicotine
PSA assay used with ADVIA Centaur systems

2 August 2016

Safety advisory - updating Instructions for Use
Urogynaecological surgical mesh complications

2 August 2016

TGA urges reporting of adverse events
Non-tuberculous mycobacterium infections associated with heater-cooler devices

2 August 2016

Alert - updated advice for health professionals and facilities following report of patient infection

July

Mi Show Slimming capsules

29 July 2016

Safety advisory
Glyceryl trinitrate tablets (Anginine and Lycinate)

27 July 2016

Update - TGA investigation
Medtronic Neuromodulation Deep Brain Stimulation system pocket adaptors

21 July 2016

Hazard alert - risk of loss of therapy due to electrical issue
Golden Ant tablets

15 July 2016

Safety advisory
Quickie Q7 manual wheelchair

12 July 2016

Recall for product correction - risk of backrest bracket breaking
Black Storm tablets

12 July 2016

Safety advisory
James Leckey Design Mygo Stander

5 July 2016

Recall for product correction - small risk of injury due to design of angle adjustment mechanism
Chlorofluor Gel

5 July 2016

Update - additional information about recall process

June

Etopophos (etoposide phosphate) powder for injection vials and Vepesid etoposide capsules

28 June 2016

Medicine shortages - anticipated
King-Wolf tablets

27 June 2016

Safety advisory
Clomifene / clomiphene

24 June 2016

Update - medicine shortages - alternative product available
MAGNA-RX capsules

23 June 2016

Safety advisory
Mercaptamine (cysteamine) and mercaptopurine

17 June 2016

Safety advisory - similarity between ingredient names mercaptamine (cysteamine) and mercaptopurine
Medtronic deep brain stimulation therapy DBS Extension models 7483 and 37086

16 June 2016

Hazard alert - risk of adverse events related to DBS tunnelling procedure
Medtronic deep brain stimulation devices - multiple models

14 June 2016

Hazard alert - risk of loss of coordination in patients' movements
Hydroxyethyl starch (Voluven and Volulyte)

10 June 2016

Update - increased risk of death and kidney injury in critically ill patients
Ethicon Physiomesh Flexible Composite Mesh

9 June 2016

Hazard alert - higher rate of recurrence/reoperation
Canagliflozin

7 June 2016

Safety advisory - potential increased risk of lower limb amputation
Zovirax Ophthalmic ointment

6 June 2016

Update - registered product now available
Glyceryl trinitrate tablets (Anginine and Lycinate)

2 June 2016

Safety advisory - reports of longer than expected time to dissolve and difficulty breaking tablets

May

Bactroban (mupirocin) 20 mg/g ointment tube

27 May 2016

Medicine shortages
Zimmer Biomet Trabecular Metal knee implant components

26 May 2016

Hazard alert - potential for post-operative infection
Medtronic RestoreSensor implantable neurostimulators

25 May 2016

Hazard alert - potential for loss of therapeutic effect due to battery charging issues
Counterfeit medicine alert: BiCNU (carmustine for injection) 100mg bottle

23 May 2016

Counterfeit version of product discovered in some countries
TRUEresult blood glucose test strips

20 May 2016

Recall - risk of undetected high blood sugar levels due to incorrect readings
Children's Panadol 5-12 years suspension 200 mL bottle

19 May 2016

Recall - risk of allergic reaction due to potential contamination
HeartWare external controller

17 May 2016

Hazard alert - risk of problems due to loose power or data connectors
Platinum 3000 Rhino 7 Capsules

16 May 2016

Safety advisory
Birmingham Hip Resurfacing system

9 May 2016

Update - new hazard alert with updated revision rates
Birmingham Hip Modular Head (used in hip replacements)

9 May 2016

Update - new hazard alert with updated revision rates
Silimed medical devices (all - including breast implants)

6 May 2016

The suspension period for all medical devices manufactured by Silimed is extended to 4 November 2016
Military Trauma and Haemorrhage Wound Dressing

3 May 2016

Recall - may break during use
Super Dragon capsules

2 May 2016

Safety advisory

April

Lang Yi Hao tablets

27 April 2016

Safety advisory
U.S. Black Gold tablets

14 April 2016

Safety advisory
MMC Zang Ba Bao tablets

14 April 2016

Safety advisory
Ranzhishou slimming capsules

11 April 2016

Safety advisory
2016 seasonal influenza vaccines

8 April 2016

Influenza vaccines can change from year to year as new strains of influenza virus appear. This is one reason vaccination against influenza …
Flu vaccine: 2016 seasonal influenza vaccines for use in children

8 April 2016

2016 influenza vaccines registered and available for use in children
Seasonal flu vaccine (all alerts)

8 April 2016

Information about seasonal flu vaccine
Super Bull 6000 Herbal capsules

1 April 2016

Safety advisory

March

Vigorexx tablets

31 March 2016

Safety advisory
Leisure Slimming capsules

30 March 2016

Safety advisory
U Slimming and U Plus Slimming capsules

30 March 2016

Safety advisory
Independent review of the efficacy and safety of over-the-counter codeine combination medicines

24 March 2016

The TGA commissioned an independent review of the safety and efficacy of low dose codeine containing products
Review of the efficacy and safety of over-the-counter codeine combination medicines

24 March 2016

Investigating the efficacy and safety of over-the-counter codeine containing combination analgesics for pain and codeine based antitussives
Update on the proposal for the re-scheduling of Codeine products

24 March 2016

The Advisory Committee on Medicines Scheduling (ACMS) met on 15 March 2016 to consider the public submissions received following the …
Betamin 100 mg vitamin B1 tablets

24 March 2016

Recall - wrong tablets included in bottles from one batch
Bexsero meningococcal B vaccine

22 March 2016

Final update - monitoring finds no new or unexpected safety issues
Idelalisib (Zydelig) 100 mg and 150 mg tablets

16 March 2016

TGA is investigating a significant safety concern involving idelalisib 100 mg and 150 mg tablets, which are marketed in Australia as Zydelig
Cancel unnecessary ARTG entries before 30 June 2016

15 March 2016

Cancel unnecessary ARTG entries before 5pm 30 June 2016 to avoid incurring an annual charge for 2016-2017
Required Advisory Statements for Medicine Labels (RASML) and the Labelling Order (TGO 69)

11 March 2016

The labels of over-the-counter and complementary medicines are often required to contain particular advisory statements about specific …
Epipen 300 Microgram Adrenaline Injection Syringe Auto Injectors

11 March 2016

Alert - reports of expired EpiPen devices supplied in cartons within expiry
Mums The One one step hCG urine pregnancy test

10 March 2016

Recall - potential decreased sensitivity and risk of false negative results
Ampicillin injection and Amoxycillin injection - medicine shortages

10 March 2016

Medicine shortage update - return of supply of Ibimicyn ampicillin injections
TGA issues safety alert about EpiPen Adrenaline Auto-injector

9 March 2016

Check that the expiry date on each EpiPen device is the same as that on the carton
Dexcom continuous glucose monitor receivers

9 March 2016

Recall for product correction - potential for audible alarms not sounding
Medtronic Reveal LINQ insertable cardiac monitor

4 March 2016

Hazard alert - potential for premature replacement alert
LCS Complete RPS Knee System (used in knee replacements)

1 March 2016

Hazard alert - higher than expected revision rate when used without patella resurfacing

February

Maxagra capsules

29 February 2016

Recall - products contain undeclared substances
ConceivePlease one step hCG urine pregnancy test

26 February 2016

Recall – potential decreased sensitivity and risk of false negative results
Excellence Losing Weight capsules

16 February 2016

Excellence Losing Weight capsules pose a serious risk to your health and should not be taken
Half Quite tablets

15 February 2016

Half Quite tablets pose a serious risk to your health and should not be taken
Veletri consumables kit

11 February 2016

Recall - small risk of infection due to potential contamination
Zhong Hua Niu Bian tablets

10 February 2016

Safety advisory
Natural Model capsules

10 February 2016

Safety advisory
Acetazolamide (Diamox) 250 mg tablets

2 February 2016

Recall - potential contamination

January

Amazon Tonic III: does not treat cancer and contains potentially dangerous ingredients

31 January 2016

Safety advisory
Flocare transition giving sets with ENFit transition adaptors

24 January 2016

Recall for product correction – potential for leakage and/or breakage
Sextra capsules

19 January 2016

Safety advisory
Jack Rabbit tablets

18 January 2016

Safety advisory
Viagra 007 tablets

13 January 2016

Safety advisory
HeartWare Ventricular Assist Device AC adapters and batteries

11 January 2016

Hazard alert - potential for loss of power

Media releases & statements

Related information

Historical media releases & statements