Apotex Pty Ltd — APO-Metformin XR 1000mg tablets

PRA number

2018/16541

Published date

Product description

APO-Metformin XR 1000mg modified release tablet blister pack 60 tablets
Batch Number E16539 only
Expiry Date 12/2019

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

Australian Register of Therapeutic Goods: AUST R 281210
Metformin plastic in tablet
Identifying features

Other identifying numbers

Batch Number E16539

What are the defects?

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.

What are the hazards?

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.

What should consumers do?

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.

Supplier

Apotex Pty Ltd

Where the product was sold

Nationally

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category