Potential Drug Recall

 

Further to DrugAlert Volume 192 and DrugAlert Volume 193 regarding the quarantine of Provive® (propofol) MCT-LCT 1%, 200mg/20mL AFT Pharmaceuticals have provided a status update on investigations into the sterility of the batches available in Australia.

Testing of multiple vials of Provive® by four different laboratories has not identified any evidence of contamination with Ralstonia. There is no evidence of contamination at the manufacturing site, or any breakdown in process during terminal sterilisation following repeated testing. There have also been no reports of infection associated with Provive® from other countries which use the drug, including Canada, UK, Germany, Poland, Italy and New Zealand.

AFT Pharmaceuticals have submitted these findings to the Therapeutic Goods Administration (TGA) and expect a result shortly following formal review.

Quarantined propofol stocks should not be returned into use until the TGA has issued formal notice to this effect. Further advice will be issued when details are available.

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, or AFT Pharmaceuticals on 1800 097 639.

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.

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