Fingolimod Glenmark 0.5 mg 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-38142990
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Fingolimod Glenmark 0.5 mg Hard Capsules | PL: 25258/0323 | fingolimod hydrochloride | 05060204167041 |
Batches (expiry): 1501919 (29/02/2027)
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.