Recall: APO-Metformin XR 1000 mg tablets

Recall – risk of injury due to potential contamination with plastic fragment

19 January 2018

Consumers and health professionals are advised that Apotex, in consultation with the TGA, is recalling one batch of APO-Metformin XR 1000 mg tablets (batch number E16539).

image of the APO-Metformin XR 1000 mg tablets.

APO-Metformin XR 1000 mg tablets are used to treat type 2 diabetes in adults and children over 10 years of age.

There has been one report of a small piece of white plastic (likely from a cable/zip tie) being embedded in a tablet from this batch. The plastic may or may not be visible, as it could be completely embedded in the tablet.

If a small piece of plastic is swallowed with the tablet there is a small risk of choking or perforation of the gastrointestinal tract. The plastic is not toxic or carcinogenic.

No other batches are affected by this recall.

Information for consumers

If you or someone you provide care for takes APO-Metformin XR 1000 mg tablets, check the batch number on the package to see if it is from the affected batch (batch number E16539).

If you have a product from the affected batch, return it to a pharmacy for a refund or replacement.

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 APO-Metformin XR 1000 mg tablets, please be aware of this issue.

Apotex is writing to pharmacists to provide further information about this issue, including details of the recall procedure. Please inspect your stock and quarantine any products from the affected batch (batch number E16539).

Patients returning unused or partially used packs should be provided a full refund or replacement.

If pharmacists or any other health professionals notice or receive reports of any suspected contamination of other batches of APO-Metformin XR 1000 mg tablets, please report it to the TGA (see the ‘Reporting problems’ section below).

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