Recalls and suspensions

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13 May 2020
Recall - potential for mould contamination
14 February 2020
Product defect correction - potential for blank labelling to pose risk of accidental misuse
29 November 2019
Recall - bacterial contamination of one batch
14 November 2019
Product defect correction – risk of delayed therapy due to potential battery issues

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Safety information

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7 July 2020
The Original 3 Bullets capsules pose a serious risk to your health and should not be taken.
6 July 2020
Safety advisory - not to be used in people with compromised immune function
29 June 2020
Counterfeit Alprazolam 2mg tablets and counterfeit Kalma 2 tablets pose a serious risk to your health and should not be taken
29 June 2020
Joint statement on accessing alternatives and patient management

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News

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6 July 2020
Guidance for sponsors and manufacturers wanting to submit data in the electronic Common Technical Document (eCTD) format
6 July 2020
Guidance for sponsors and manufacturers wanting to submit data in the NeeS format
6 July 2020
SARA database - enhanced search facility
6 July 2020
Australian Public Assessment Report for Ixekizumab

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