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Interpharma Pty Ltd is recalling all batches of Sodium Chloride 0.9% 30mL ampoules due to potential contamination with Ralstonia pickettii.
ARTG No. | Item No. | Batch No. | Expiry date |
|---|---|---|---|
370471 & 370408 | INTRPH-AIN001 | All | All |
This product has been distributed to healthcare facilities, medical clinics and pharmacies nationally.
What is the problem?
We are aware of Ralstonia pickettii cases in patients in multiple states and territories.
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 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.
Preliminary testing now indicates the possible presence of R. pickettii in some batches of this product. While the results are yet to be confirmed, we have made the decision to recall all batches of InterPharma Sodium Chloride 0.9% 30mL ampoules.
What do I need to do?
If you have any batch of Interpharma Sodium Chloride 0.9% 30mL ampoules, do not use them.
Return the product to your place of purchase for a refund or contact Interpharma on the number below to organise a refund.
What are the risks?
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.
Further information
Please contact Interpharma Pty Ltd on 1300 340 353 for any further information.
We are currently reviewing other products made by the same manufacturer, Legency Remedies Private. We will provide an update on these as information becomes available.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to our monitoring of these products. For more information see our Incident Reporting and Investigation Scheme (IRIS).
We cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.