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

See a list of details to help identify the product

Reason 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.

The hazards 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.

Details to help identify the product

Supplier running the recall

Apotex Pty Ltd

Identifying product features

Batch Number MK0903.
Expiry date February 2017.

Where the product was sold

Nationally

Responsible regulators

Regulators are established or appointed by government. They enforce regulations and rules.

Quote PRA number 2016/15641 when contacting a regulator about this recall.

Recall and remedy questions

Contact the Therapeutic Goods Administration if you have:

  • a question about the remedy being offered to you by the business that is responsible for managing this recall, or
  • concerns about the way the business is managing this recall.