Recalls and suspensions

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16 July 2021
Update - further information for consumers
3 June 2021
Product Defect Alert - child-resistant caps may not function correctly
21 May 2021
Recall due to unacceptable risk in pregnancy
6 April 2021
Product defect correction - lid magnet may dislodge and cause early battery depletion

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Safety information

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27 July 2021
Product Information documents for parenteral iron products are currently being updated to include information about fetal bradycardia and Kounis syndrome.
26 July 2021
The Product Information for nifedipine has been updated to provide new information about the risk of acute pulmonary oedema when used as a tocolytic agent (inhibiting myometrial smooth muscle contractions) for the treatment of preterm labor in pregnancy.
26 July 2021
The Product Information for ocrelizumab has been updated to include a warning and further information about late onset neutropenia.
22 July 2021
Health professionals are advised that the Product Information (PI) documents for methylphenidate products have been updated with new information about use in pregnancy.

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News

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27 July 2021
The purpose of this document is to guide developers and users of software to decide which software and apps are medical devices
26 July 2021
Advancing Australia's health through international regulatory engagement
23 July 2021
The TGA has issued an infringement notice for $2,664 to an individual from Canberra, for a breach of the Therapeutic Goods Act 1989 in relation to the alleged unlawful advertising of a homoeopathic medicine with COVID-19 claims.
23 July 2021
Australian prescription medicine decision summary

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