BTC Rosuvastatin 10 mg tablets

Recall - potential missing blister sheets

14 June 2017

Consumers and health professionals are advised that Apotex, in consultation with the TGA, is recalling one batch of BTC Rosuvastatin 10 mg tablets (batch number F4250, expiry date 08/2019).

It has been identified that this medicine may have been dispensed with missing blister sheets, which means affected packs would not contain the correct amount of tablets.

BTC Rosuvastatin 10 mg tablets are used to lower high cholesterol levels.

Information for consumers

If you or someone you provide care for takes BTC Rosuvastatin 10 mg tablets, please check the batch number (displayed on the packs and blister sheets) to see if it is affected by this recall.

If you have a pack that has been affected by this issue, return any unused medicine to your pharmacy for a refund.

In the event that there are no anomalies with your product, you can choose to continue using it as normal.

If you notice any other anomaly with the product, or if If you have any other questions or concerns about this issue, talk to your health professional or contact Apotex on 1800 276 839.

Information for health professionals

If you treat patients who take BTC Rosuvastatin 10 mg tablets, please be aware of this issue.

Apotex has written to pharmacists providing further information about this issue, including details of the recall process.

Please inspect your stock and quarantine all packs from the affected batch before returning them to your wholesaler.

Patients returning affected packs of BTC Rosuvastatin 10 mg tablets should be provided a full refund and, if possible, offered an equivalent product to ensure continuation of therapy and avoid any risks of discontinuation symptoms. An alternative can only be offered on presentation of a valid prescription, or emergency arrangements if allowed under your jurisdictional legislation. All stock returned to you by the patient must be returned to the wholesaler.

If you have any further questions or concerns about this issue, please contact Apotex 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.