Drug Recall

 

HPS Pharmacies wish to advise that Alexion Australasia, in consultation with the Therapeutic Goods Administration (TGA), have given notice of a drug recall of:

Soliris® Intravenous Infusion
(eculizumab ‘rmc’)
300mg/30mL vial,
Aust R 138885

Batch No.

Expiry

P0000508

31/07/2014

P0001107

31/12/2014

P0001404

28/02/2015

P0001901

31/08/2015

P0002002

31/08/2015

 

This recall has been issued due to visible particles being identified in a limited number of vials of Soliris® (eculizumab ‘rmc’) concentrated solution for intravenous infusion which were distributed within another country, but manufactured using the same process as those distributed in Australia.

At present, no serious adverse events have been identified due to particulate matter. No supply shortages are expected as other batches are available for immediate use.

Please inspect your stocks and quarantine all units from the above batches for return to Alexion Australasia, who will arrange for replacement. Any items supplied by HPS Pharmacies should be returned to the pharmacy for processing.

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 Alexion Australasia directly on (02) 9091 0500.

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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