Potential Drug Recall

 

Further to DrugAlert Volumes 192, DrugAlert Volume 193, and DrugAlert Volume 196, the Therapeutic Goods Administration (TGA) have now released their findings regarding the investigation into propofol 1%, 200mg/20mL injections.

More than 1,700 vials of propofol were tested by the TGA and three external laboratories, and satisfied criteria for sterility and bacterial endotoxins. No samples demonstrated the presence of the suspect organism, Ralstonia pickettii.

The quarantine is now lifted, and all propofol stocks may be returned into use. This includes batches A030906 (expiry date 08/15) and A030907 (expiry date 08/15) of Provive MCT-LCT 1% emulsion for injection which were the particular batches initially quarantined.

Health professionals are reminded that rubber stoppers and the outer surfaces of injection vials are not sterile and to always use aseptic technique, including proper disinfection, and to allow the surfaces to dry before piercing the vial.

Retain this notice in a prominent position, including in other related business units for one month. 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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