Baclofen 10mg Tablets
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 4 defect notification · DMRC - 37308281
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Baclofen 10mg Tablets | PL: 36722/0105 | baclofen | 05060637641187 |
Batches (expiry): EBJ25001F01 (31/01/2028), EBJ25002F01 (31/01/2028), EBJ25003F01 (31/01/2028)
Background: Special Concept Development UK Limited has informed the MHRA that the Patient Information Leaflet (PIL) for the batches in the table do not contain the correct safety information. An updated Summary of Product Characteristics (SPC) is now available. The safety information missing in the PIL and previous SPC is summarised below: PIL Section 2, What you need to know before you take baclofen