This safety alert provides an update to our Safety alert: potential contamination of some saline products with Ralstonia pickettii.
We're continuing to investigate and take action about the potential contamination of some saline products with Ralstonia pickettii, with local health departments.
Recall of Interpharma 30ml Ampoules
Following further investigation, all batches of the sodium chloride 0.9% 30 mL ampoules (ARTG IDs: 370471 and 370408) supplied by Interpharma Pty Ltd are now being recalled. See Recall: Interpharma Sodium Chloride 0.9% 30mL ampoules | Therapeutic Goods Administration (TGA) for further information.
Quarantine of other saline products
As a precautionary measure, we have now 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
- 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.
To date, 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 these products have not been supplied in Australia.
The four batches of sodium chloride 0.9% 10mL ampoules supplied by Interpharma, described in our Safety alert: potential contamination of some saline products with Ralstonia pickettii remain quarantined.