Recall published

Topics

Cosmetic and health products
Pharmacy and medical products

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

See a list of details to help identify the product.

Metformin plastic in tablet

Reason 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.

Details to help identify the product.

Supplier running the recall

Apotex Pty Ltd

Identifying numbers

Other identifying numbers

Batch Number E16539

Where the product was sold

Nationally

Responsible regulators

Regulators are established or appointed by government. They enforce regulations and rules.

Quote PRA number 2018/16541 when contacting a regulator about this recall.

Recall and remedy questions

Contact the Therapeutic Goods Administration if you have:

  • a question about the remedy being offered to you by the business that is responsible for managing this recall, or
  • concerns about the way the business is managing this recall.