药 物 回 收
|
| |
| Australia: Recall: Interpharma Sodium Chloride 0.9% 30ml ampoules (English only) |
| |
Therapeutic Goods Administration (TGA) announces that Interpharma Pty Ltd is recalling all batches of Sodium Chloride 0.9% 30ml ampoules (ARTG No.: 370471 and 370408) due to potential contamination with Ralstonia pickettii.
TGA is aware of Ralstonia pickettii cases in patients in multiple states and territories. On 24 Nov 2023, TGA 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, TGA has made the decision to recall all batches of InterPharma Sodium Chloride 0.9% 30ml ampoules.
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.
TGA is currently reviewing other products made by the same manufacturer, Legency Remedies Private. TGA will provide an update on these as information becomes available.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/safety/product-recalls/recall-interpharma-sodium-chloride-09-30ml-ampoules
In Hong Kong, the above products are not registered pharmaceutical products. There is also no registered pharmaceutical product manufactured by Legency Remedies Private. Related news was previously issued by TGA, and was posted on the Drug Office website on 29 Nov 2023.
Ends/Friday, Dec 1, 2023
Issued at HKT 15:00
|
| |
|
