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TGA

 •  October 24, 2017

Following two cycles of public consultation on the regulation of autologous human cell and tissue products in 2015 and 2016, the Government has decided that changes to regulation should be implemented. As a result of the changes, some of these products will be subject to regulation as biologicals by the TGA, with the level of regulation being...

TGA

 •  October 6, 2017

Consumers and health professionals are advised that Pfizer Australia, in consultation with the TGA, is recalling 10 batches of Gentamicin Injection BP 80 mg in 2 mL Steriluer ampoules in packs of 10 and 50. Gentamicin Injection belongs to a group of medicines known as aminoglycoside antibiotics, which work by preventing bacteria from growing and...

TGA

 •  September 12, 2017

Consumers and health professionals are advised that LivaNova, in consultation with the TGA, has issued a hazard alert regarding certain models of Platinium Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds). LivaNova is also recalling unused stock of these devices. ICDs are implantable...

TGA

 •  August 11, 2017

Consumers and health professionals are advised that Pfizer, in consultation with the TGA, is undertaking a recall for product correction of one batch (Batch A473, expiry date Feb 2019) of Heparin 5000 IU/5 mL injection 50 pack ampoules because of the potential for the packaging to contain another product. Users with potentially affected products...

TGA

 •  August 11, 2017

Consumers and health professionals are advised that Pfizer, in consultation with the TGA, is undertaking a recall for product correction of one batch (Batch A313, expiry date Nov 2017) of Lignocaine 50 mg/5 mL ampoules because of the potential for the packaging to contain another product. Users with potentially affected products are asked to...

TGA

 •  August 11, 2017

Consumers and health professionals are advised that Pfizer, in consultation with the TGA, is undertaking recalls for product correction involving Heparin 5000 U/5 mL injection 50 pack (Batch A473, expiry date Feb 2019) and Lignocaine 50 mg/5 mL ampoules (Batch A313, expiry date Nov 2017) due to the potential for incorrect products in packages....

TGA

 •  July 19, 2017

Pharmaceutical company Novo Nordisk A/S, in consultation with the TGA, has initiated a consumer level recall of some batches of their NovoPen Echo insulin cartridge holder after detecting there is a possibility they may crack or break if exposed to chemicals in certain cleaning agents. People using a device with a cracked or broken cartridge...

TGA

 •  July 14, 2017

Consumers and health professionals are advised that Novo Nordisk, in consultation with the TGA, is recalling six batches of NovoPen Echo insulin injection pens after detecting that there is a risk that the insulin cartridge holder component may crack or break if exposed to chemicals in certain cleaning agents. NovoPen Echo insulin injection pens...

TGA

 •  July 11, 2017

Consumers and health professionals are advised that Novo Nordisk, in consultation with the TGA, is recalling six batches of NovoPen Echo insulin cartridge holders after detecting that there is a risk that they may crack or break if exposed to chemicals in certain cleaning agents. NovoPen Echo insulin cartridge holders are used for insulin...

TGA

 •  July 11, 2017

Pharmaceutical company Novo Nordisk A/S, in consultation with the TGA, has initiated a consumer level recall of some batches of their NovoPen Echo insulin cartridge holder after detecting there is a possibility they may crack or break if exposed to chemicals in certain cleaning agents. People using a device with a cracked or broken cartridge...