Product Notification

 

HPS Pharmacies wish to advise that Pfizer Australia has given notice of a product notification for Clopine® Suspension as follows:

Clopine® Suspension
Clozapine 50mg/mL
ARTG 142239

The only affected batches are listed below:

Product

Expected Return Date

95632

28th February 2018

A0480

30th June 2018

A1045

31st August 2018

 

This product notification has been issued following a low number of 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.

Please inspect your stock and only quarantine bottles observed to display the above changes in appearance. While this issue has only been reported with the three batches stated above, it is recommended that all future supplies of Clopine® Suspension are also visually inspected as a precaution.

If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect all stock stored in the designated imprest areas at the earliest opportunity. All affected products will be quarantined for return to the supplier and HPS Pharmacies will arrange for replacement stock as soon as possible. An HPS Pharmacies staff member will contact senior medical and nursing staff if there is an immediate impact to your facility.

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 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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