HPS Pharmacies wish to advise that the Therapeutic Goods Administration (TGA), have recommended a temporary quarantine of:
Provive® Injection Vials 5 x 20mL
Aust. R: 118938
Batch No.: A040656
This notice has been issued pending the results of investigations into an unusual number of reports of adverse reactions to this batch of Provive® 1% injection vial. Shivering, rigors, and pyrexia have been reported, usually occurring subsequent to recovery, and resolving within 24 hours.
This advice has been issued in the context of the Product Information stating that shivering is a common adverse reaction, occurring in more than 10% of patients, and furthermore that:
“During the recovery phase vomiting, headache and shivering occurred in about 2% of the patients, with nausea occurring more frequently.”
Please inspect your stocks and quarantine on-site all units from the above batch. Further advice will be issued when additional information is known, at which time stock may be returned to use, or returned to your supplier.
No other batches or presentations of Provive® are affected by this recall, including Provive® MCT-LCT 1% injection vial (Aust. R: 162318).
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 contact your Pharmacist at HPS Pharmacies, or AFT Pharmaceuticals on 1800 AFTPHARM.
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.