Cabergoline (Dostinex and Cabaser) 0.5 mg, 1 mg and 2 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 cabergoline 0.5 mg tablets (marketed as Dostinex) and cabergoline 1 mg and 2 mg tablets (marketed as Cabaser).

Dostinex 500 microgram tablets pill bottle and packaging Cabaser 1 milligram tablets pill bottle and packaging Cabaser 2 milligram tablets pill bottle and packaging

Cabergoline 0.5 mg tablets (Dostinex) are used to supress lactation for medical reasons or treat patients with excess production of a hormone called prolactin.

Cabergoline 1 mg and 2 mg tablets (Cabaser) are used to treat Parkinson's disease.

It has been identified that bottles of these medicines have been supplied without child-resistant caps.

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

To correct this issue, Pfizer Australia has initiated a recall for product correction to replace all bottles of cabergoline tablets marketed as Dostinex and Cabaser, irrespective of batch number or expiry date.

Information for consumers

If you or some you care for is taking cabergoline tablets (marketed as either Dostinex or Cabaser), please return the medicine to your pharmacy so that the bottle can be replaced with one that has a child-resistant cap.

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 cabergoline tablets marketed as Dostinex or Cabaser, advise them of this issue. Instruct them to return their medicine to their pharmacy so that the bottle can be replaced with one that has a child-resistant cap.

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.

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 cabergoline (Dostinex or Cabaser), transfer the previously dispensed medicines into a new bottle with a child-resistant cap.

When dispensing new prescriptions for these medicines, please supply them in a new bottle with a child-resistant cap.

Pfizer Australia will supply suitable bottles 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.