Baclofen 10mg/5ml Oral Solution
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 2 recall · DMRC-38317957
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Baclofen 10mg/5ml Oral Solution | PL: 39307/0090 | baclofen | 5055935104700 |
Batches (expiry): EBB25001A1 (31/03/2027), 150ml (30/07/2025), EBB24001A1 (30/09/2026), 150ml (17/02/2025)
Background: Syri Limited, T/A SyriMed is recalling the above batches of product as a precautionary measure due to crystallisation observed over time in the oral solution. Testing results show that the assay of the filtered oral solution does not comply with the licensed specification of the product and there is a potential risk of sub-therapeutic dosing. The recall is at pharmacy and wholesaler level. Advice for Healthcare Professionals: Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.