MHRA issues Class 4 Medicines Defect Information for paracetamol
Posted: 2 April 2020 | Victoria Rees (European Pharmaceutical Review) | No comments yet
A barcode for paracetamol 250mg/5ml oral suspension displays the wrong strength when scanned, prompting the MHRA to announce the defect information.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced a Class 4 Medicines Defect Information alert for paracetamol 250mg/5ml oral suspension (500ml) produced by Rosemont Pharmaceuticals.
According to Rosemont Pharmaceuticals, there is an error in the barcode of the GTIN number of the label on the bottle of certain batches which can be found here.
When scanned, the barcode identifies the bottle as paracetamol 120ml/5ml oral suspension instead of paracetamol 250mg/5ml oral suspension.
The product is not subject to a recall and the strength printed on the bottle label is correctly stated as paracetamol 250mg/5ml oral suspension. The barcode and the GTIN number on the outer box is correct and identifies the strength correctly.
The MHRA advises healthcare professionals and patients to identify the product strength using the labelled contents rather than the scanned barcode.
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UK Medicines and Healthcare products Regulatory Agency (MHRA)
