MHRA 发布 Sun Pharmaceutical 芬戈莫德 SUN 0.5mg 硬胶囊 Class 3 召回（批号 HAF2945A）

Contents

1. DMRC reference number
2. Marketing Authorisation Holder
3. Medicine Details
   1. Fingolimod SUN 0.5mg hard capsules
4. Affected Lot Batch Numbers
5. Background
6. Advice for Healthcare Professionals
7. Advice for Healthcare Professionals to Provide to Patients
8. Additional information
9. Download document

DMRC reference number

DMRC - 37582999

Marketing Authorisation Holder

Sun Pharmaceutical Industries Limited

Medicine Details

Fingolimod SUN 0.5mg hard capsules

PL: 31750/0173

Active Ingredient: fingolimod (as hydrochloride)

SNOMED code: 41496911000001109

GTIN: 8718531949683

Affected Lot Batch Numbers

Background

Sun Pharma UK Limited is conducting a precautionary recall of a single batch of Fingolimod SUN 0.5 mg hard capsules due to reports of capsule breakage on removing from the blister. No other batches of Fingolimod SUN 0.5mg hard capsules are impacted.

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 Healthcare Professionals to Provide to Patients:

Patients who have received Fingolimod SUN 0.5mg hard capsules from batch HAF2945A are advised to continue to take the capsules and, where possible, pierce the foil before removing the capsule. The capsule contents are not impacted by this issue. Patients who are experiencing capsules breaking upon removal from the blister should speak to their dispensing pharmacist in the first instance.

The recall is being actioned at the wholesaler and pharmacy levels.

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

Additional information:

For all medical information enquiries and information on this product, please email [email protected], or telephone 020 8848 5050 / 07974754551.

For stock control enquiries please email [email protected], or telephone 020 8848 5050.

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

[email protected]

Download document

Class 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Fingolimod SUN 0.5mg hard capsules, EL(25)A/49