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

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

Drug alert number: EL(24)A/56

Date issued: 25 November 2024

The Medicines and Health products Regulatory Agency (MHRA) has issued a Class 3 medicines defect information notice for: Baclofen 10mg/5ml Oral Solution (Syri Limited, T/A SyriMed)

Company name: Syri Limited, T/A SyriMed

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

SNOMED Code: N/A

Batch Number Expiry Date Pack Size First Distributed
EBB23004A1 31 May 2025 15 Jul 2024 01-Oct-2023

Active Pharmaceutical Ingredient: baclofen

Brief description of the 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 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.

View full alert here.

Advice for 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.

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.