Plastic fragment recall

recall regulatory

Apotex and the TGA are advising of a recall of a batch of metformin

Apotex, in consultation with the TGA, is warning consumers and health professionals that it is recalling a batch of APO-Metformin XR 1000 mg tablets (batch number E16539).

There has been a report of a small piece of white plastic – likely from a cable or zip tie – embedded in a tablet from this batch.

“The plastic may or may not be visible, as it could be completely embedded in the tablet,” Apotex and the TGA say.

“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.”

They are advising patients and their carers to check the batch number on any packets of AJP-Metformin XR 1000mg to see whether it is from the affected batch, and to return any product from the affected batch to a pharmacy for refund or replacement.

plastic fragment in metformin

Apotex says it is writing to pharmacists to provide further information about the issue, including details of the recall procedure.

It has asked them to inspect their stock and quarantine any from batch number E16539.

“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,” it says.

For further information contact Apotex on 1800 276 839.

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