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| Australia: Safety alert and product recalls: updated advice following Ralstonia pickettii contamination of some saline products (English only) |
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Therapeutic Goods Administration (TGA) announces that it is continuing to investigate and take action on the potential contamination of some saline products with Ralstonia pickettii.
The quarantine of the four batches of Sodium Chloride 0.9% 10ml ampoules supplied by Interpharma (described in the TGA’s safety alert on 28 Nov 2023) is now lifted and these products can be returned to the supply chain. Further testing has not identified Ralstonia pickettii in these products and no Ralstonia pickettii cases have been reported as associated with their use.
Preliminary testing indicates the presence of Ralstonia pickettii in additional saline products manufactured at Legency Remedies Private. All batches of these other products are now being recalled from the Australian market:
- Logiwash Sodium Chloride for Irrigation 0.9% (ARTG 404417; sponsored by Ironbark Creek Investments)
- T3030 – Legency Remedies Sodium Chloride 0.9% Irrigation ampolues 30ml (ARTG 409695; sponsored by YES Medical)
As a precautionary measure, TGA has now quarantined all batches of one other sodium chloride 0.9% product. This product is manufactured in the same facility, Legency Remedies Private:
- Aerowash Eyewash and Wound Irrigation 15 ml and 30 ml (ARTG 159438; sponsored by Aero Healthcare Pty Ltd)
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-alerts/safety-alert-and-product-recalls-updated-advice-following-ralstonia-pickettii-contamination-some-saline-products
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, 1 Dec 2023 and 2 Dec 2023.
Ends/Monday, Dec 18, 2023
Issued at HKT 15:30
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