Recalls and suspensions

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14 September 2021
Recall due to risk of bacterial contamination
2 August 2021
Recall - Possible presence of benzene
3 June 2021
Product Defect Alert - child-resistant caps may not function correctly

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Safety information

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11 November 2021
Information about the TGA's safety monitoring of COVID-19 vaccines.
9 November 2021
TGA investigation – potential contamination of medicines with nitrosamine impurities
9 November 2021
TGA is working with international regulators and sponsors to investigate and address nitrosamine impurities in medicines.
4 November 2021
Information about the TGA's safety monitoring of COVID-19 vaccines.

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News

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12 November 2021
Submissions published and summarised as part of a consultation on medical devices that are substances for introduction into the body.
12 November 2021
TGA decision: VeraSeal (human fibrinogen/ human thrombin) is approved to treat hemostasis.
12 November 2021
Amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 will alter sponsor requirements device adverse event reporting
12 November 2021
Guidance document updated to include final report and additional information requirements following amendments to the Therapeutic Goods (Medical Devices) Regulations 2002

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