Xyntha 500IU dual-chamber syringe - batch number H19478

Related information

Recall - incorrect labelling

24 April 2014

Consumers and health professionals are advised that Pfizer Australia, in consultation with the TGA, is recalling one batch of its Xyntha 500IU dual-chamber syringe.

Xyntha 500IU dual-chamber syringe contains the medicine moroctocog alfa, also known as recombinant coagulation factor VIII. It helps blood to clot and is used to treat people with haemophilia A.

There has been one confirmed case of a Xyntha 500IU dual-chamber syringe from batch number H19478, which was distributed in Australia between 31 July 2013 and 9 January 2014, being incorrectly labelled.

The contents of the syringe was Xyntha 500IU (consistent with the carton packaging), but the syringe itself was incorrectly labelled with a European ReFacto AF label. Xyntha 500IU and ReFacto AF contain the same medicine, but have different brand names. The ReFacto AF brand name is not used in Australia.

To address this issue, Pfizer Australia is recalling the affected batch, including products already supplied to patients.

Please note, there have been no reports of adverse events relating to this issue.

No other batches of Xyntha 500IU dual-chamber syringe or other Pfizer Australia products are affected by this recall.

Information for consumers

Pfizer Australia has contacted all affected patients and distributors, providing further information about this issue, including details about the recall process.

If you have any Xyntha 500IU dual-chamber syringes, you can check the batch number (located on the bottom right-hand corner on the front of the pack) to confirm that it is not from batch number H19478.

If you find any products from the affected batch, call Pfizer Australia on 1800 112 218 to arrange for them to be recovered and replacement stock issued.

Only Xyntha 500IU dual-chamber syringes from this batch are affected by this recall.

Please note, even if you have a Xyntha 500IU dual-chamber syringe from the affected batch or have used one of these products in the past, the medicine contained in the syringe is correct and the likelihood of you experiencing a problem as a result of this issue is low.

If you have any questions or concerns about this issue, talk to your health professional or call Pfizer Australia on 1800 112 218.

Information for health professionals

Pfizer Australia has contacted all affected patients and distributors, providing further information about this issue, including details about the recall process.

If you have any Xyntha 500IU dual-chamber syringes in stock, check the batch number (located on the bottom right-hand corner on the front of the pack) to see if it is from batch number H19478.

If you find any products from the affected batch, quarantine those products and call Pfizer Australia on 1800 112 218 to arrange for them to be recovered and replacement stock issued.

Only Xyntha 500IU dual-chamber syringes from batch number H19478 are affected by this recall.

If you are treating a patient who is using Xyntha 500IU dual-chamber syringes, please make sure they are aware of this issue. Reassure them that, even if they have used a product from the affected batch in the past, the medicine contained in the syringe is correct and the likelihood of them experiencing a problem as a result of this issue is low.

If you have any questions or concerns about this issue, call Pfizer Australia on 1800 112 218.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA’s monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.