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

Source: MHRA / Gov.uk  17.5.22

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 name

Mefenamic Acid 500mg film coated tablets PLPI 20774/1591

Batch number Company’s Reference Expiry date Pack size First distributed
107082 6949U 04/2023 30 03/2022

Brief description of the 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 for 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.

Further Information

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

Recipients of this Medicines Recall 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.

Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

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

 

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