GovWire

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DMRC reference number

DMRC-33999722

Company name

Syri Limited, T/A SyriMed

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

SNOMED Code

N/A

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 suppliers approved process.

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 theMHRA 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.

Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

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