GovWire

MDR number

MDR 019-10/22

Company name

Flamingo Pharma UK Ltd

Product name

Ibuprofen 400mg Tablets, PL 43461/0005

Active Pharmaceutical Ingredient: Ibuprofen

Product name

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. Please see images in the attachment highlighting the 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. See the image for information on where to find this information on the blister in the attachment.

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

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