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

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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.”

National Patient Safety Alert Reference Number: NatPSA/2022/007/MHRA

Mexiletine hydrochloride 50mg Hard Capsules – PL 31644/0027

Batch Number Expiry Date Pack Size First Distributed
2111216 02/2024* 84 capsules 10/02/2022

*Per correction by Clinigen Healthcare Ltd, an update was made to correct the expiry date to reflect 02/2024

Mexiletine hydrochloride 100mg Hard Capsules – PL 31644/0028

Batch Number Expiry Date Pack Size First Distributed
2111217 04/2024 84 capsules 10/02/2022

Mexiletine hydrochloride 200mg Hard Capsules – PL 31644/0029

Batch Number Expiry Date Pack Size First Distributed
2111218 04/2024 100 capsules 10/02/2022

Active Pharmaceutical Ingredients: mexiletine hydrochloride

Suppliers has been asked to stop supplying the impacted batch immediately.

GPs and pharmacists are requested to Identify and immediately contact all patients who have been dispensed the impacted batch and ask them to confirm if they have remaining stock within their possession. “If batch traceability information is not available, all patients dispensed this product since 10 February 2022 should be contacted,” said MHRA.

“If the pharmacist identifies any patients with an impacted batch, they should, in the first instance, contact the patient’s GP and discuss alternative mexiletine treatment of the patient. As this is a specialist use product and patients may require monitoring, other clinicians and healthcare professionals may need to be involved.”

“Discuss the risk of cardiac arrhythmias with patients and advise them to seek urgent medical attention if they experience any new or worsening of symptoms of an arrhythmia including palpitations, angina pain, chest discomfort, dizziness and loss of consciousness.”

The authority has also warned, “the risks of suddenly stopping medication for ventricular arrhythmias is higher than the potential risk presented by continuing to take capsules containing too much or too little of the active ingredient. This product should only be recalled from patients when it has been confirmed that the patient has access to an alternative mexiletine product.”

MHRA has advised healthcare professionals to be aware that other licensed preparations for mexiletine are available. “Whilst licensed mexiletine products marketed by Clinigen Healthcare Ltd are out of stock, the only other licensed mexiletine product available is Namuscla 167mg (equivalent to 200mg mexiletine hydrochloride) hard capsules, Summary of Product Characteristics (SmPC).”

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