Key Summary
- One batch of Fingolimod Glenmark 0.5 mg is being recalled after stability test concerns.
- Pharmacies must stop supplying the batch and return it; patients don’t need to act.
- Patients should contact a healthcare professional if they notice side effects.
Glenmark Pharmaceuticals Europe is recalling a batch of Fingolimod Glenmark 0.5 mg hard capsule as a precautionary measure due to unsatisfactory stability test results on 21 January.
The medicine is being recalled under the Medicines and Healthcare products Regulatory Agency (MHRA) Class 3 alert, indicating a quick preventive removal of medicines from the market.
It is being recalled to avoid potential consequences from a delay in the capsule dissolution.
Pharmacy teams and healthcare professionals are advised to stop supplying medications from this batch and return them to the supplier at the earliest.
The recall is being undertaken at a pharmacy and wholesaler level; hence no action is required from patients.
Patients who had consumed the medicine from the specific batch are urged to reach out to the nearest healthcare providers if they are experiencing any adverse reaction.
The active ingredient of Fingolimod Glenmark 0.5 mg hard capsule is fingolimod hydrochloride and it is used to treat multiple sclerosis.
