The Therapeutic Goods Administration (TGA) has issued a safety alert for sodium chloride 0.9% 10 mL ampoules and sodium chloride 0.9% 30 mL ampoules.
Affected product details:
|
Sodium chloride 0.9% 10 mL ampoules |
Sodium chloride 0.9% 30 mL ampoules |
|---|---|
|
Item number INTRPH-DMO200 CH2 Product code: 2048147 Symbion product code: 107557 Batches: 2304400, 2301530, 2301531 and 2207874 |
Item number INTRPH-AIN001 CH2 Product code: 2457101 Symbion product code: 654299 Batches: 2386043E, 2386048E, 2386051E and 2286030E |
The TGA has identified that some batches of above mentioned products were likely to have been used in a cluster of patients who tested positive for Ralstonia pickettii. The link between these cases and the Interpharma products has not yet been confirmed, therefore, the goods have not been recalled from the market at this time. As a precautionary measure, the TGA has quarantined these products until further notice.
Note that no registered veterinary products are affected by this issue, however, it’s possible that veterinarians may use the product for reconstitution of veterinary medicinal products.