MHRA Class 3 Medicines Recall: Fingolimod 0.5 mg Hard Capsules (Glenmark Pharmaceuticals Europe Ltd)

Class 4 Medicines Defect Information: Fingolimod 0.5 mg Hard Capsules (Glenmark Pharmaceuticals Europe Ltd)

Drug alert number: EL (24)A/39

Date issued: 19 August 2024

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 3 medicines defect information notice for: Fingolimod 0.5 mg Hard Capsules (Glenmark Pharmaceuticals Europe Ltd)

Company name: Glenmark Pharmaceuticals Europe Ltd

Product name: Fingolimod 0.5 mg Hard Capsules, PL 25258/0323

SNOMED Code: 41463711000001102

Active Pharmaceutical Ingredient: Fingolimod Hydrochloride

Brief description of the problem

Glenmark Pharmaceuticals Europe Ltd is recalling the above batches after retesting showed out of specification results. The tabled batches are being recalled as a precautionary measure after testing showed variability of the capsule contents beyond permitted levels.

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.

View full alert here.

Advice for 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.

Further Information

For medical information enquiries please use the following options: by phone +44 8004 580 383 or email medical_information@glenmarkpharma.com

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