MHRA Class 2 Recall because of Blister Pack Mislabeling

On 4 March 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a Class 2 recall for Boots Paracetamol 500 mg tablets (16s). The recall was triggered by a customer complaint identifying an error in the product’s foil blister, which incorrectly labeled the contents as ‘Aspirin 300 mg Dispersible Tablets’. Although the tablets inside were confirmed to be paracetamol, the mislabeling posed a risk of medication errors, potentially leading to incorrect usage and patient confusion.

The recall required immediate action within 48 hours to remove affected products from the supply chain.

Advice for stakeholders: Retailers, wholesalers, and healthcare professionals were instructed to quarantine and return the affected stock. Patients who received the product should stop using it and return it to Boots for a refund.

This incident highlights the importance of effective Quality Management Systems (QMS) and Good Distribution Practice (GDP) compliance in preventing medication errors.

26-04-2025

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