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Class 4 medicines defect information issued for Flamingo Pharma’s Ibuprofen 400mg tablets

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The Medicines and Healthcare products Regulatory Agency has issued a class 4 medicines defect information for Flamingo Pharma’s Ibuprofen 400mg Tablets, EL (22)A/04.

The medicine manufacturer has 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.

Batch Number Expiry Date Pack Size First Distributed
1403444 12/2025 24 06 September 2021

 

Advice for pharmacists

The impacted products are within specification and there is no issue with product quality. Therefore, the affected batches are not being recalled.

Healthcare professionals, including community pharmacy teams, 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.

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Current Issue December 2023

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