Class 2 Medicines Recall: Quadrant Pharmaceuticals Ltd, Mefenamic Acid 500mg film coated tablets, EL (22)A/23

Quadrant Pharmaceuticals Ltd are recalling a specific batch of Mefenamic Acid 500mg Film-Coated Tablets as a precautionary measure, due to observations of a defective layer of film coating in some tablets, resulting in the tablet core being partially exposed.

MDR Number: MDR 183-04/22

Company name: Quadrant Pharmaceuticals Ltd

Product description: Mefenamic Acid 500mg film coated tablets PLPI 20774/1591

Details of the affected batch:

Brief description of problem:

Quadrant Pharmaceuticals Ltd are recalling the affected batch as a precautionary measure, due to observations of a defective layer of film coating in some tablets, resulting in the tablet core being partially exposed.

Advice to Healthcare Professionals:

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Advice to patients:

No further action is required by patients as this is a Pharmacy and Wholesaler level recall.

Although the Marketing Authorisation Holder have not received any reports of adverse reactions related to the issue above, patients who experience adverse reactions or insufficient control of symptoms should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information:

For more information, medical or supply enquiries, please contact joanne.fishwick@maxearn.co.uk or radoslaw.bandomir@maxearn.co.uk

To access the full recall: Class 2 Medicines Recall: Quadrant Pharmaceuticals Ltd, Mefenamic Acid 500mg film coated tablets, EL (22)A/23