Mefenamic acid (Ponstan) 250 mg capsules, bottles of 50

Recall - 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 of mefenamic acid 250 mg capsules (marketed as Ponstan) sold in bottles of 50.

Ponstan pill bottle

Mefenamic acid capsules are used for the short-term treatment of period pain, heavy periods and short-term management of mild to moderate pain.

It has been identified that mefenamic acid capsules in bottles of 50 have been supplied without child-resistant caps.

This recall does not affect mefanamic acid (Ponstan) 250 mg capsules in blister packs, which can be purchased from a pharmacy without a prescription.

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 of all mefenamic acid capsules in bottles of 50, irrespective of batch number or expiry date.

Information for consumers

If you or some you care for is taking mefenamic acid capsules (marketed as Ponstan) sold in bottles of 50, please visit your doctor to arrange a new prescription or discuss alternative treatments. 

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

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 mefenamic acid sold in bottles of 50, 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 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.

Please inspect your stock and quarantine any affected products.

Before a patient returns a bottle of mefenamic acid (Ponstan), consider advising them to see their doctor to discuss alternative treatments to ensure continuation of therapy.

Pfizer Australia 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 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.