Apotex-Pantoprazole 40 mg and 20 mg tablets

Update – additional strength affected

1 June 2017

Consumers and health professionals are advised that, in addition to one batch of Apotex-Pantoprazole 40 mg tablets (see below), Apotex is also recalling Apotex-Pantoprazole 20 mg tablets (batch number F5314, expiry date 11/2018).

It has been identified that Apotex-Pantoprazole 20 mg tablets from the affected batch may have been dispensed with missing blister sheets.

If you or someone you provide care for takes Apotex-Pantoprazole 20 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 an affected pack please return it 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.


Recall - potential missing blister sheets

26 May 2017

Consumers and health professionals are advised that Apotex, in consultation with the TGA, is recalling one batch of Apotex-Pantoprazole 40 mg tablets (batch number F4442, expiry date 10/2018).

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.

Apotex-Pantoprazole 40 mg tablets belong to a group of medicines called proton pump inhibitors (PPIs). PPIs work by decreasing the amount of acid the stomach makes, to give relief from the symptoms of ulcers, reflux disease and Zollinger-Ellison syndrome, and allow healing to take place.

Information for consumers

If you or someone you provide care for takes Apotex-Pantoprazole 40 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.

If you have any other questions or concerns about this issue, talk to your health professional.

Information for health professionals

If you treat patients who take Apotex-Pantoprazole 40 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 unused or partially used packs of Apotex-Pantoprazole 40 mg tablets should be provided a full refund. If the patient has a valid prescription (or repeat prescription) or if they meet Schedule 3 supply requirements as per the Poisons Standards, they should be offered an equivalent product to ensure continuation of therapy.

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.