Product Notification Update

 

Further to DrugAlert Volume 389, HPS Pharmacies wish to advise that Pfizer Australia has given notice of a product notification for all batches of Clopine® Suspension as follows:

Clopine® Suspension
Clozapine 50mg/mL
ARTG 142239

This product notification has been issued following some complaints regarding the adherence of crystals on the walls of the bottle which may also be visible throughout the suspension. These crystals typically do not re-suspend upon shaking, or the suspension may not be as free-flowing as normal. There have not been any reports of adverse effects related to this issue.

Pfizer is currently working with the manufacturer to resolve this matter which may lead to changes in the formulation or manufacturing process. In the meantime, the shelf-life of Clopine® Suspension has been reduced to 12 months.

Please inspect your stock and only quarantine bottles observed to display the above changes in appearance.

Retain this notice in a prominent position, including in other related business units until supplies return to normal. 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 Pfizer on 1800 675 229.

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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