Class 4

Class 4 Medicines Defect Information: Flamingo Pharma UK Ltd, Ibuprofen 400mg Tablets, EL (22)A/04

Flamingo Pharma UK Ltd have identified an error relating to the embossed batch number on some cartons of Ibuprofen 400mg tablets.

MDR Number: MDR 199-01/22

Company name: Flamingo Pharma UK Ltd

Product description: Ibuprofen 400mg Tablets PL 43461/0005

Details of the affected batch:

Batch Number

Expiry Date

Pack Size

First Distributed

1403444

12/2025

24

06 September 2021

Brief description of problem:

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.

Advice to 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.

Company contacts for further information:

Flamingo Pharma

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

Or

Mawdsley Brooks & Co Ltd Overlabellingcustomerservices@mawdsleys.co.uk 01302 553064

To access the full recall: Class 4 Medicines Defect Information: Flamingo Pharma UK Ltd, Ibuprofen 400mg Tablets, EL (22)A/04