Fingolimod SUN 0.5mg hard capsules
What this means
The MHRA has issued a medicines recall or defect notification. Class 1: risk to life, immediate recall. Class 2: may cause mistreatment or harm, recall within 48 hours. Class 3: unlikely to cause harm, recall within 5 days. Class 4 (defect notification): no recall, caution in use. The medicine remains licensed; only the listed batches are affected. Do not stop treatment without speaking to your doctor or pharmacist.
Class 3 recall · DMRC - 37582999
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Fingolimod SUN 0.5mg hard capsules | PL: 31750/0173 | fingolimod (as hydrochloride) | 8718531949683 |
Batches (expiry): HAF2945A (30/11/2027)
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.