Recall: PROVIVE MCT-LCT 1% propofol 200mg/20mL emulsion for injection vial, impurity detected
A recall has been issued for PROVIVE MCT-LCT 1% propofol 200mg/20mL emulsion for injection vial, with product code AIN00545 and lot number A0E0051, distributed between 3 August 2022 and 10 March 2022 by Baxter Healthcare, due to the detection of an impurity, propofol dimer.
The level of impurity is within the 0.5% limit set by US Pharmacopeia; therefore, the administration of this solution is not expected to pose a safety risk.
Affected customers are advised to locate and remove affected product from facilities. Return to Baxter Healthcare in exchange for a credit using the form in the customer letter.
For more information, refer to the Therapeutic Goods Administration Australia recall notice and the Medsafe New Zealand recall notice.