| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2022-RN-01243-1 |
| Product Name/Description |
PROVIVE MCT-LCT INJ. 1% 20ML GV
Product code: AIN00545
Lot number: A0E0051
ARTG 162318
(PROVIVE MCT-LCT 1% propofol 200mg/20mL emulsion for injection vial) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
27/09/2022 |
| Responsible Entity |
|
| Reason/Issue |
During stability testing of related substances for Propofol 10mg/mL with MCT-LCT, 20mL GV, out of specification results were observed. The test results for impurity E (PropofolDimer) were 0.34% with a specification limit of not more than (NMT) 0.25% and individual impurity result of 0.12% with a specification limit of NMT 0.10%.The test results for impurity E (Propofol Dimer) were 0.34%. The level of Impurity E being present in the Propofol solution is within the 0.5% limit set by US Pharmacopeia, therefore the administration of this solution is not expected to pose a safety risk.
The affected product was distributed between 03/08/2021 and 10/03/2022.
No adverse health consequences are expected as a result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to locate and remove the affected product from their facilities. Customers should complete the reply form (supplied to impacted facilities by the sponsor) to arrange for a credit and return of any impacted product to Baxter. |
| Contact Information |
1800 229 837 - Baxter Healthcare Customer Service |