Recalls and suspensions

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22 May 2019
Recall – potential for reduced effectiveness
21 May 2019
Recall - risk of liver injury
29 April 2019
Recall - ingestion of plastic fragments may pose potential choking hazard
16 April 2019
Statement on the post-market review of heater-coolers has been updated

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Safety information

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17 May 2019
Update to Mesh Hub notifying of recent recall actions
3 May 2019
The TGA has commenced its review and laboratory testing of samples received from the sponsors of breast implants in Australia
2 May 2019
Update 4 - continuing medicine shortage
2 May 2019
Update - medicine shortage resolved

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26 June 2019
Guidance for sponsors seeking to obtain Good Manufacturing Practice (GMP) clearance
25 June 2019
Minor amendments to exclusion criteria of autologous HCT products
24 June 2019
The transition period for updating medicine ingredient names ends on 30 April 2020.
24 June 2019
Added Regorafenib (Stivarga) and Sarilumab (rch)(Kevzara)

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