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 reference number
DMRC-38317957
Marketing Authorisation Holder
Syri Limited, T/A SyriMed
Medicine Details
Baclofen 10mg/5ml Oral Solution
PL: 39307/0090
Active ingredient: baclofen
SNOMED code: 38757711000001104
GTIN: 5055935104700
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 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.
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 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/
Additional 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
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
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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