Methotrexate (DBL Methotrexate Tablets) 2.5 mg tablets, bottles of 30

Consumers and health professionals are advised that Hospira, in consultation with the TGA, has initiated a recall of methotrexate (marketed as DBL Methotrexate Tablets) 2.5 mg tablets in bottles of 30.

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 DBL Methotrexate Tablets 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, Hospira has initiated a recall of bottles of 30 methotrexate 2.5 mg tablets, marketed as DBL Methotrexate Tablets, with the following batch numbers:

• 1418883 (expiry date September 2015)
• 1530004 (expiry date March 2017)
• 1530005 (expiry date April 2017)
• 1554385 (expiry date August 2017)

Information for consumers

If you or someone you care for is taking methotrexate tablets (marketed as DBL Methotrexate Tablets), and you do not have a prescription to obtain replacement medicine, please visit your doctor to arrange a new prescription or discuss alternative treatments.

After that, return the methotrexate tablets to your pharmacy. A refund will be provided for any returned medicine.

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 Hospira on 1300 046 774 (choose option 2).

Information for all health professionals

If you are treating a patient who is taking methotrexate tablets (marketed as DBL Methotrexate Tablets), advise them of this issue. You may need to provide a new prescription or discuss alternative treatments before instructing them to return their medicine to their pharmacy.

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 Hospira on 1300 046 774.

Information for pharmacists

Hospira has written to pharmacists providing further information about this issue, including details of the process for this recall.

Please inspect your stock and quarantine any affected products.

Before a patient returns a bottle of methotrexate (marketed as DBL Methotrexate Tablets), check to ensure that they have a prescription to obtain replacement medicine or have spoken with their doctor to ensure continuation of care.

Hospira will arrange credit for all refunds given.

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 Hospira on 1300 046 774.

Reporting problems

Consumers and health professionals are encouraged to 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.