A batch of metformin extended-release tablets has been recalled by the manufacturer after bits of plastic were found embedded in the pills.
The TGA has advised that Apotex is recalling a batch of APO-Metformin XR 1000 mg tablets (batch number E16539) and is urging clinicians and patients to be vigilant for possible contamination of the product.
“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 regulator says.
The regulator says only one batch of APO-Metformin XR 1000 mg tablets is affected by the recall, and the plastic is unlikely to be toxic or carcinogenic
“If a small piece of plastic is swallowed with the tablet there is a small risk of choking or perforation of the gastrointestinal tract,” it said.
“If you treat patients who take APO-Metformin XR 1000 mg tablets, please be aware of this issue.”
Patients should be advised to return unused or partially used packs to the pharmacy, where they will be given a replacement or a refund.
Metformin extended release products – including APO-Metformin XR 1000 mg tablets – have been subject to ongoing supply problems since 2016, but the TGA announced that stocks were available from mid 2017.