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
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
Reasons the product is recalled
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.
The hazards to consumers
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 consumers should 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.
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.