TGA suspects one facility at the root of multiple recalls

Published: 22-Feb-2024

Nationwide quarantines and recalls have been carried out on multiple saline products in Australia following a cluster of patients in private hospitals in Queensland testing positive for Ralstonia Pickettii. Amnah Badr from Cleanroom Technology explains

The Therapeutic Goods Administration (TGA) in Australia has been investigating the root cause of many patients testing positive for Ralstonia Pickettii.

Cases of the bacteria in patients began cropping up in November 2023 across multiple states and territories in Australia.

Working with state and territory health departments, the TGA now suspects that this contamination occurred during the manufacturing of the product at the Legacy Remedies Private facility, an India-based manufacturer of small-volume parenteral products.

However, this is yet to be confirmed as the TGA is still in the investigation stage.

The bacteria

R. Pickettii is a bacteria which is found in the natural environment and in bodies of water such as lakes and rivers.

The bacteria is typically harmless for humans but poses a risk to those with weakened immune systems and to those who have had the bacteria come into contact directly with their bloodstream.

The investigation

Cases of the bacteria first appeared in late November of 2023 and investigations are still ongoing into early 2024.

The majority of the contamination cases have occurred in private hospitals in Queensland, Australia but multiple other cases have been detected across the different states and territories for patients within the country.

As it stands, cases of Ralstonia Pickettii have been identified amongst groups of patients across Australia and the sponsors of the saline bags, Interpharma, are working in support of the TGA as part of the investigation.

On 24 November 2023, the TGA initiated a nationwide quarantine for some Interpharma saline products after the investigation identified that some batches of these products were likely to have been used in a cluster of patients who tested positive for R. pickettii

Cases of the bacteria first appeared in late November of 2023

The national quarantine was imposed on some of Interpharma’s saline products covering three on the Australian Register of Therapeutic Goods (ARTG). However, none of these products have so far been revealed as the cause of the cases.

This quarantine then turned into a recall on the 1st December. 

On this date, the quarantine was also expanded to two otter companies identified through the investigation. These companies are Ironbark Creek Investments and YES Medical, both for some of their sodium chloride products.

On the 18th December these quarantines also then turned into recalls, and yet another product was placed on quarantine from Aero Healthcare. Aero also used the same manufacturer, Legacy Remedies.

This quarantine was also turned into a recall on 21st December. 

Investigations are still ongoing in 2024 on behalf of the safety of the patients. Yet, as the investigations have not yet revealed a link between the saline products and the patients - the goods have not been removed from the market.

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