MHRA Class 4 Medicines Defect Information: Ibuprofen 400mg Tablets, Paracetamol 500mg Tablets (Caplets) (Flamingo Pharma UK Ltd)

Class 4 Medicines Defect Information:

Ibuprofen 400mg Tablets, Paracetamol 500mg Tablets (Caplets) (Flamingo Pharma UK Ltd)

Drug alert number: EL (22)A/43

Date issued: 12 October 2022

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:

Ibuprofen 400mg Tablets, PL 43461/0005

Active Pharmaceutical Ingredient: Ibuprofen

Paracetamol 500mg Tablets (Caplets), PL 43461/0078

Active Pharmaceutical Ingredient: Paracetamol

Brief description of the problem

Flamingo Pharma UK Ltd has identified an error relating to the ink printing of the batch number and expiry date on the carton for three batches of Ibuprofen 400mg tablets. The batches where this defect has been confirmed are batches 20242, 20277 and 20316. The batch number and expiry date are either missing on the carton or the printing is misaligned, which may affect readability. The batch numbers and expiry dates on the blisters within the cartons are clear and present, therefore these impacted batches are not being recalled at this stage. In addition to the three batches of the ibuprofen product affected (20242, 20277, and 20316), Flamingo Pharma UK Ltd cannot exclude that the other batches of paracetamol and ibuprofen are potentially impacted by this issue.

Flamingo Pharma UK Ltd has confirmed that the quality and safety of the product is not impacted, and the batch numbers and expiry dates on the blisters within the cartons are clear and present.

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 outer carton before dispensing the affected products to ensure the batch number and expiry is present and 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.

Additionally, some batches of Paracetamol 500mg tablets (caplets) have been distributed to retail stores. Staff there are conducting visual checks of the outer carton to ensure that only packs with batch numbers and expiry dates present are available for consumers/patients to purchase.

Advice for patients

Patients should note the information relating to missing batch numbers and expiry dates on some packs of Ibuprofen 400mg Tablets marketed by Flamingo Pharma UK Ltd, and the potential for other batches of Ibuprofen 400mg Tablets and Paracetamol 500mg tablets (caplets) to be impacted. There are no concerns about the safety or quality of the medicine. If you find a carton with no batch number or expiry date, please refer to the blister for the correct batch number and expiry date. If you have any additional concerns, please inform your healthcare professional.

View full alert here.

For further information 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