Muscle relaxant recalled due to risk of sub-therapeutic dosing

Syri Limited – trading as SyriMed – is recalling two batches of the muscle relaxant drug, Baclofen, as a precaution after crystallisation was observed over time in the oral solution.

Testing showed that the assay of the filtered oral solution does not comply with the licensed specification of the product, creating a potential risk of sub-therapeutic dosing.

The affected product is Baclofen 10mg/5ml oral solution (150ml). The recall is at pharmacy and wholesaler level.

Baclofen is indicated for the relief of spasticity of voluntary muscle resulting from such disorders as multiple sclerosis and other spinal lesions – for example, syringomyelia, motor neurone disease, transverse myelitis.

Pharmacies are advised to stop supplying the affected batches immediately, quarantine all remaining stock, and return it to the supplier using the supplier’s approved process.

Affected lot batch numbers (150ml pack size):

• EBB25001A1
• EBB24001A1

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