Potential Drug Recall
Further to DrugAlert Volume 192, HPS Pharmacies wish to advise that the Therapeutic Goods Administration (TGA) has extended the notice to quarantine Provive® (propofol) MCT-LCT 1%, 200mg/20mL injection vial batches A030906 and A030907 to also recommend avoiding all presentations of propofol from the manufacturer, where possible, as follows:
Propofol 1%, 10mg/mL emulsion for injection
|118938||Provive® 20mL||Claris Lifesciences Australia Pty Ltd|
|118939||Provive® 50mL||Claris Lifesciences Australia Pty Ltd|
|118940||Provive® 100mL||Claris Lifesciences Australia Pty Ltd|
|162318||Provive® MCT-LCT 20mL||Claris Lifesciences Australia Pty Ltd|
|162319||Provive® MCT-LCT 20mL||Claris Lifesciences Australia Pty Ltd|
|162320||Provive® MCT-LCT 20mL||Claris Lifesciences Australia Pty Ltd|
|148870||Propofol Sandoz® 20mL||Sandoz Pty Ltd|
|148871||Propofol Sandoz® 50mL||Sandoz Pty Ltd|
|148872||Propofol Sandoz® 100mL||Sandoz Pty Ltd|
Given that approximately 80% of the Australian market utilise the Provive® brand, this quarantine is expected to be significant and requires careful management to ensure minimal disruptions to hospital operations.
Propofol 1%, 10mg/mL emulsion for injection is also distributed in Australia as;
- Diprivan® (AstraZeneca Pty Ltd)
- Fresofol®, and Fresofol® MCT/LCT (Fresenius Kabi Australia Pty Limited), and
- Propofol-Lipuro® (B Braun Australia Pty Ltd).
These specific brands are unaffected and the distributors have advised that sufficient supplies are held to satisfy the immediate demand. HPS Pharmacies has obtained stock to meet the needs of its regular clients for a period of three months and does not expect stock shortages at this time.
Please inspect your stocks and quarantine on-site all units described above. Further advice will be issued when details are known, at which time stock may be returned to use, or returned to your supplier.
Retain this notice in a prominent position, including in other related business units for one month in case stock is in transit. Report any problems identified with medicines, vaccines or medical devices to the TGA.
Should you require further information regarding this matter, please do not hesitate to contact your pharmacist at HPS Pharmacies.
Information regarding expected dates for supply may vary subject to delays which are out of our control. HPS Pharmacies does not accept responsibility for such changes but will endeavour to keep our clients updated as information is made available from drug manufacturers or wholesalers.