Drug Recall


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

Xyntha® 500IU Dual-chamber Syringe


moroctocog alfa (rch)
(recombinant coagulation factor VIII)

Aust R


Batch No.



May 2015


This recall has been issued due to the potential for the Xyntha® 500IU dual-chamber syringe within the outer carton to be mislabelled with “ReFacto AF“, the brand name used in Europe. The medicine within the syringe is correct and adverse events related to using any mislabelled product are not expected.

No other batches or presentations of Xyntha® are affected by this recall, including Xyntha® 500IU powder for injection plus pre-filled diluent syringe (Aust R 161715). No supply shortages are expected, as newer batches containing the correct product packaging have been released into circulation.

Please inspect your stocks and quarantine all units from the above batch for return to Pfizer Australia, 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 Pfizer Australia on 1800 112 218.

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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