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
For the full article and to download the document please click HERE
