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APO-Cabergoline 500 mcg tablets

Recall - potential for degradation due to moisture

2 September 2016

Consumers and health professionals are advised that Apotex, in consultation with the TGA, is recalling one batch of APO-Cabergoline 500 mcg tablets due to a packaging issue which could potentially lead to the product degrading over time in moist conditions.

APO-Cabergoline is a medicine used to prevent the production of breast milk in women after giving birth, or to treat abnormally high levels of prolactin.

APO-Cabergoline packaging, including pill bottle and container

The affected batch is MK0903, with an expiry date of February 2017. The batch number is displayed on the bottom flap of the carton as well as on the side of the bottle label.

Information for consumers

If you, or someone you provide care for, use APO-Cabergoline please check the batch number displayed on the bottle label or the base of the carton.

If the product is from batch MK0903, please return it to the pharmacy where it was purchased for a refund or a replacement product.

If you have any concerns or queries, speak to your health professional or contact Apotex Medical Information on 1800 195 055.

Information for health professionals

Apotex has written to pharmacists providing more details about this issue and the recall procedure.

If you are treating a patient who is using APO-Cabergoline 500 mcg tablets please alert them to this issue. If they have tablets from the affected batch (MK0903) advise them to return it to the dispensing pharmacy for a refund or a replacement product.

If you have any questions about this issue or the recall procedure, contact Apotex customer service on 1800 276 839.

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.