Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Ltd, Fingolimod 0.5 mg Hard Capsules, EL(24)A/39
Glenmark Pharmaceuticals Europe Ltd is recalling this batch after retesting showed out of specification results.
MDR number
MDR 113-05/23
Company name
Glenmark Pharmaceuticals Europe Ltd
Fingolimod 0.5 mg Hard Capsules, PL 25258/0323
SNOMED Code
41463711000001102
| Batch No | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 1306526 | 31-May-2025 | 28 | 17-Oct-2023 |
| 1306528 | 31-May-2025 | 28 | 06-Feb-2024 |
| 1400709 | 30-Nov-2025 | 28 | 27-Feb-2024 |
| 1400710 | 30-Nov-2025 | 28 | 15-Mar-2024 |
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.
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
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.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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