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Mexiletine hydrochloride recall

Contact affected patients for alternative supplies

August 5th 2022

Tagged: MHRA alert

By MHRA

Clinigen Healthcare is recalling three batches of mexiletine hydrochloride due to over/under dosing concerns.

The affected batches are:

Mexiletine hydrochloride 50mg Hard Capsules, PL 31644/0027

Batch numberExpiry datePack sizeFirst distributed
211121602/202484 capsules10/02/2022

Mexiletine hydrochloride 100mg Hard Capsules , PL 31644/0028

Batch numberExpiry datePack sizeFirst distributed
211121704/202484 capsules10/02/2022

Mexiletine hydrochloride 200mg Hard Capsules, PL 31644/0029

Batch numberExpiry datePack sizeFirst distributed
211121804/2024100 capsules10/02/2022

Stability testing has identified that some individual capsules on the market may fall outside the individual fill-weight range, raising the potential for some capsules to contain too little or too much active ingredient.

Clinigen Healthcare Ltd 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.

Healthcare teams are asked to quarantine all remaining stock and return it to suppliers/MAHs using the approved process

Patients dispensed affected products should be offered an alternative product and advised to monitor symptom control. Patients should be advised not to stop any treatments without consulting their relevant healthcare professional.

Alternative options include Namuscla 167mg (equivalent to 200mg mexiletine hydrochloride) hard capsules and special order items.