MHRA recalls Mexiletine hydrochloride 50mg, 100mg & 200 mg hard capsules

Three batches of Mexiletine hydrochloride 50mg, 100mg and 200 mg hard capsules manufactured by Clinigen Healthcare has been recalled.

Pharmacists are urged to quarantine the said batches and return it to the supplier by or before 12 August.

Clinigen Healthcare Ltd has initiated a recall of three batches of Mexiletine hydrochloride hard capsules due to a potential risk of under dose or overdose, which
could have consequences for the safety of patients.

The manufacturer has confirmed that no alternative batches of Mexiletine hydrochloride 50mg, 100mg or 200mg hard capsules will be available until later in the year,
therefore the recall of these batches from patients should only be considered where patients have access to appropriate alternative products. See below for more
information on resupplying patients with alternative products.

“Patients should be advised not to stop any treatments without consulting their relevant healthcare professional. The risks of suddenly stopping medication for
ventricular arrhythmias is higher than the potential risk presented by too much or too little of the active ingredient in the capsule.”