Methotrexate (Methoblastin) 2.5 mg and 10 mg tablets

Recall for product correction - bottles supplied without child-resistant caps

11 March 2015

Consumers and health professionals are advised that Pfizer Australia, in consultation with the TGA, has initiated a recall for product correction of methotrexate (marketed as Methoblastin) 2.5 mg tablets in bottles of 30 and 10 mg tablets in bottles of 15 and 50.

Methoblastin 2.5 milligram tablet pill bottle and packaging Methoblastin 10 milligram tablet pill bottle and packaging

Methotrexate tablets are used to treat rheumatoid arthritis, severe psoriasis and some types of cancer.

It has been identified that bottles of methotrexate marketed as Methoblastin have been supplied without child-resistant caps.

Please note that there is no concern regarding the quality or safety of this medicine, other than the absence of child-resistant packaging.

To correct this issue, Pfizer Australia has initiated a recall for product correction to replace the caps on all bottles of methotrexate marketed as Methoblastin, irrespective of batch number or expiry date.

Information for consumers

If you or some you care for is taking methotrexate tablets (marketed as Methoblastin), please return the medicine to your pharmacy so that the cap on the bottle can be replaced with one that is child-resistant.

In the meantime, continue taking your medicine as prescribed.

You are reminded that all medicine should always be kept out of the reach of children, as stated on the product packaging.

If you have any questions or concerns about this issue, contact your health professional or Pfizer Australia on 1800 675 229.

Information for all health professionals

If you are treating a patient who is taking methotrexate tablets marketed as Methoblastin, advise them of this issue. Instruct them to return their medicine to their pharmacy so that the cap on the bottle can be replaced with one that is child-resistant.

Reassure patients that there is no other concern regarding the quality or safety of this medicine, but consider reminding them of the importance of keeping all medicine out of the reach of children.

If you have any questions or concerns about this issue, contact Pfizer Australia on 1800 675 229.

Information for pharmacists

Pfizer Australia has written to pharmacists providing further information about this issue, including details of the process for this recall for product correction.

If a patient returns a bottle of methotrexate (Methoblastin), replace the existing cap with a child-resistant cap.

When dispensing a new prescription for this medicine, please supply it with a child-resistant cap.

Pfizer Australia will supply suitable caps and will replace any used from your own stock.

Reassure patients that there is no other concern regarding the quality or safety of these medicines, but consider reminding them of the importance of keeping all medicine out of the reach of children.

If you have any questions or concerns about this issue, contact Pfizer Australia on 1800 675 229.

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.