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
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 1403444 | 12/2025 | 24 | 06 September 2021 |
Active Pharmaceutical Ingredient: Ibuprofen
Brief description of the 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 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
For medical information and stock control queries please contact:
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
Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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