Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Limited, Fingolimod Glenmark 0.5 mg Hard Capsules, EL(26)A/02

Glenmark Pharmaceuticals Europe Limited is recalling one batch after stability testing showed out-of-specification results. The batch is being recalled as a precautionary measure following test results that showed a delay in capsule dissolution.

DMRC Number: DMRC-38142990

Company name: Glenmark Pharmaceuticals Europe Limited

Product description: Fingolimod Glenmark 0.5 mg Hard Capsules- PL: 25258/0323, SNOMED code: 41463711000001102, GTIN: 05060204167041

Details of the affected batch:

Background information: 

Glenmark Pharmaceuticals Europe Limited is recalling the above batch after stability testing showed out-of-specification results. The batch is being recalled as a precautionary measure following test results that showed a delay in capsule dissolution.

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 recall is being undertaken at a Pharmacy and Wholesaler level as a precautionary measure. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information: 

For medical information enquiries please email medical_information@glenmarkpharma.com   or telephone +44 8004 580 383

For stock control enquiries please email orders.uk@glenmarkpharma.com

To access the full recall/alert: Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Limited, Fingolimod Glenmark 0.5 mg Hard Capsules, EL(26)A/02