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| Australia: Safety alert: action following potential contamination of some saline products with Ralstonia pickettii (English only) |
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Therapeutic Goods Administration (TGA) announces that it is continuing to investigate and take action about the potential contamination of some saline products with Ralstonia pickettii.
As a precautionary measure, the TGA has quarantined two other sodium chloride 0.9% products that are manufactured in the same facility as the Interpharma product:
- ‘Yes Medical’ Non-antimicrobial wound irrigation solution, saline, sterile; sponsored by YES Medical (ARTG ID: 409695; All batches)
- Logiwash Sodium Chloride for Irrigation 0.9% 30 mL, sponsored by Ironbark Creek Investments (ARTG ID: 404417; All batches).
These products are manufactured by Legency Remedies Private, India.
As of 1 Dec 2023, no Ralstonia pickettii cases have been reported as being associated with these other products. There are two additional products on the ARTG that are manufactured at the same facility, but those products have not been supplied in Australia.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-alerts/safety-alert-action-following-potential-contamination-some-saline-products-ralstonia-pickettii
In Hong Kong, the above products are not registered pharmaceutical products. There is also no registered pharmaceutical product manufactured by Legency Remedies Private. Related news was previously issued by TGA, and was posted on the Drug Office website on 29 Nov 2023 and 1 Dec 2023.
Ends/ Saturday, December 2, 2023
Issued at HKT 12:00
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