MHRA Class 4 Medicines Defect Information: Ibuprofen 400mg tablets (Flamingo Pharma UK Ltd)

Class 4 Medicines Defect Information: Ibuprofen 400mg Tablets (Flamingo Pharma UK Ltd)

Medicines Notification number: EL (22) A/04

MDR Number: MDR 199-01/22

Date issued: 01 February 2022

The Medicines and Health products Regulatory Agency (MHRA) has issued a Class 4 Medicines Defect Information:

Ibuprofen 400mg Tablets

Flamingo Pharma UK Ltd have identified an error relating to the embossed batch number on some cartons of Ibuprofen 400mg tablets. The batch number is illegible on some cartons and poses a risk to traceability in the event of a future recall or a medical enquiry. The batch numbers on the blisters within the cartons are clear and present. Additionally, the expiry date is still visible and clearly marked on the carton and blister.

Ibuprofen 400mg Tablets PL 43461/0005

Active Pharmaceutical Ingredient: Ibuprofen

Advice for healthcare professionals

The impacted products are within specification and there is no issue with product quality. Therefore, the affected batches are not being recalled. Healthcare professionals should check the blisters before dispensing the affected batch to ensure the batch number can be read. In the event of a future recall or medical enquiry, the batch number on the blister should be referred to if the number on the carton cannot be read.

A small proportion of these packs have been overlabelled by Mawdsley Brooks & Co Ltd and they have confirmed they will contact customers directly to inform them of this issue.

Further Information

Full Medicines Notification can be viewed here

For medical information and stock control queries please contact:

Flamingo Pharma

For medical information Email: safety@flamingopharma.co.uk or general product enquiry Email: sales@flamingopharma.co.uk  Telephone: +44 (0) 7733522465

Or

Mawdsley Brooks & Co Ltd

Email: Overlabellingcustomerservices@mawdsleys.co.uk Telephone: 01302 553064