MHRA 发布 Glenmark 的 Fingolimod Glenmark 0.5 mg 硬胶囊 3 级药品召回 EL(26)A/02
Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Limited, Fingolimod Glenmark 0.5 mg Hard Capsules, EL(26)A/02
MHRA 缺陷药品报告中心发布 3 级药品召回，Glenmark Pharmaceuticals Europe Limited 召回 Fingolimod Glenmark 0.5 mg 硬胶囊批号 1501919（DMRC-38142990）。
召回起因于稳定性试验出现胶囊溶出延迟的超出标准结果，通报列出受影响批号、有效期以及对医疗专业人员和患者的处置建议。
Contents
- DMRC reference number
- Marketing Authorisation Holder
- Medicine Details
- Affected Lot Batch Numbers
- Background
- Advice for Healthcare Professionals
- Advice for Patients
- Additional information
- Download document
DMRC reference number
DMRC-38142990
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited
Medicine Details
Fingolimod Glenmark 0.5 mg Hard Capsules
PL: 25258/0323
Active Ingredient: fingolimod hydrochloride
SNOMED code: 41463711000001102
GTIN: 05060204167041
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 1501919 | 29/02/2027 | 28 | 09/10/2025 |
Background
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 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.
Additional information:
For medical information enquiries please email [email protected] or telephone +44 8004 580 383
For stock control enquiries please email [email protected]
Recipients of this Medicines Notification 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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来源：MHRA 药品召回与缺陷通报 · gov.uk