PRA number
2016/15641
Published date
Product description
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.
AUST R 218126
AUST R 218126
Why the product is recalled
Apotex Pty Ltd is recalling one batch of the APO-Cabergoline 500mcg tablets (batch MK0903, expiry date February 2017) due to a packaging issue, where the desiccant may not protect the product from moisture throughout its shelf life.
What the hazards are to consumers
Failure to protect the product from moisture could lead to the product degrading over time in moist conditions. Product degradation may affect the efficacy of the product.
What consumers should do
If you, or someone you provide care for use APO-Cabergoline, please check the batch number displayed on the bottle label or base of the carton.
If the product is from batch MK0903, return the product 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.
Supplier
Apotex Pty Ltd
Where the product was sold
Nationally
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.