Class 3 Medicines Recall: Syri Limited, T/A SyriMed, Baclofen 10mg/5ml Oral Solution, EL(24)A/56

Syri Limited, T/A SyriMed is recalling this batch of product as a precautionary measure due to crystallisation observed over time in the oral solution.

DMRC/MDR Number: DMRC-33999722

Company name: Syri Limited, T/A SyriMed

Product description: Baclofen 10mg/5ml Oral Solution, PL 39307/0090

Details of the affected batch: 

Brief description of problem:

Syri Limited, T/A SyriMed is recalling the above batch 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. The recall is at pharmacy and wholesaler level.

Advice to 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 to Patients:

No further action is required by patients as this is a pharmacy and wholesaler level recall. Patients should continue to take medicines from this batch as prescribed by your healthcare professional.

Do not stop taking baclofen suddenly without medical advice as you may get withdrawal side effects.

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

Company contacts for further information:

For medical information enquiries please email medinfo@syrimed.co.uk, or telephone +44 (0) 330 1359 422.

For stock control enquiries please email syriwholesale@bnsthamelabs.com.

To access the full recall: Class 3 Medicines Recall: Syri Limited, T/A SyriMed, Baclofen 10mg/5ml Oral Solution, EL(24)A/56