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See updated information, including recall and quarantine action, at Safety alert: action following potential contamination of some saline products with Ralstonia pickettii.
We are aware of Ralstonia pickettii cases in patients across multiple states and territories. We are working closely with state and territory health departments to investigate the possible role of therapeutic goods.
On 24 November 2023, we took the precautionary measure of initiating a nationwide quarantine for some Interpharma saline products to minimise possible risk to patients. This decision was made 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.
The link between these cases and the Interpharma products has not yet been confirmed and therefore the goods have not been recalled from the market at this time.
As at 28 November 2023, the quarantine affects 3 products on the Australian Register of Therapeutic Goods (ARTG). These are:
- Sodium Chloride 0.9% 10 ml ampoules (AUST R 235989)
- Batch numbers 2304400, 301530, 2301531, 2207874
- Sodium Chloride 0.9% 30 ml ampoules (ARTG entries 370471 and 370408)
- All batches.
The sponsor of these products, Interpharma Pty Ltd, is working with us as part of the investigation.
R. pickettii is a bacteria commonly found in the natural environment. It rarely causes infection in humans but may cause infection in people with weakened immune systems.
We will publish updates as new information becomes available.