Class 2 Medicines Recall: Syri Limited, T/A SyriMed, Baclofen 10mg/5ml Oral Solution, EL(26)A/06

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

DMRC Number: DMRC-38317957

Company name:Syri Limited, T/A SyriMed

Product description: Baclofen 10mg/5ml Oral Solution - PL: 39307/0090, SNOMED code: 38757711000001104, GTIN: 5055935104700

Details of the affected batches:

Background information: 

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 to Healthcare Professionals: 

Stop supplying the above batches 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 these batches 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 on https://yellowcard.mhra.gov.uk/

Company contacts for further information: 

For medical information enquiries please use the following options:

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/alert: Class 2 Medicines Recall: Syri Limited, T/A SyriMed, Baclofen 10mg/5ml Oral Solution, EL(26)A/06