The Therapeutic Goods Administration (TGA) has issued safety alerts for the following 0.9% sodium chloride products:
Products |
ARTG number/s |
Batches |
Action |
---|---|---|---|
InterPharma Sodium chloride 0.9% 30 mL ampoules |
370471 (inhalation) 370408 (irrigation) |
All batches |
|
YES Medical – Nonantimicrobial wound irrigation solution, saline, sterile Product also known as: |
409695 |
All batches |
|
Irrigation fluid, medical/surgical procedure – Ironbark Creek Investments Product also known as: |
404417 |
All batches |
|
Aero Healthcare – Irrigation fluid, medical/surgical procedure Product also known as: |
159438 |
All batches |
The above actions have been taken by the TGA while investigating the potential contamination of certain saline products with Ralstonia pickettii.
The TGA has lifted quarantine for InterPharma Sodium Chloride 0.9% 10 mL ampoule (ARTG – 235989).
Note that no registered veterinary products are affected by this issue; however, it is possible that veterinarians may use the affected products for reconstitution of veterinary medicinal products.