Skip to content
Search

Latest Stories

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.”

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

Mexiletine hydrochloride 50mg Hard Capsules – PL 31644/0027

Batch NumberExpiry DatePack SizeFirst Distributed
211121602/2024*84 capsules10/02/2022

*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 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

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).”

More For You

The Complete Anti-Inflammatory Guide - a useful resource for pharmacists to support patient health and wellbeing

Chronic inflammation is linked to more than 50 per cent of all deaths worldwide and one in five cancers.

The Complete Anti-Inflammatory Guide - a useful resource for pharmacists to support patient health and wellbeing

When Hemant Patel was struck down by Covid, he was determined to discover what was it that led to the disease having a devastating impact on the lives of people who seemed be healthy – the culmination of his journey is the book, The Complete Anti-Inflammatory Guide.

“I was gasping for breath and counting the number of days I might be alive when I was infected with Covid,” reveals Patel.

Keep ReadingShow less
Cargo plane unloading pharmaceuticals at US airport amid tariff concerns and stockpiling

Imports jumped in particular from Ireland, the top drug exporter to the US

Pic credit: iStock

Pharma imports to US surged in March as drugmakers look to avoid tariffs

Pharmaceutical imports to the US surged in March as drugmakers stocked up ahead of potential US tariffs on their products, which have historically been exempt from such fees.

Total imports of pharmaceutical products exceeded $50 billion in the month - the equivalent of 20 per cent of all pharmaceutical imports in 2024, according to data from a U.S. Commerce Department report on Tuesday.

Keep ReadingShow less
Scottish community pharmacist working in high street pharmacy with supportive environment

The PDA wants investment to reach those who deliver services to patients every day

Pic credit: iStock

Funding boost in Scotland “needs to work for not just pharmacy owners but pharmacists too”, says PDA

An increase in funding for community pharmacies in Scotland needs to lead to a greater focus on supporting pharmacists rather than “simply sustain business models”, according to the Pharmacy Defence Association (PDA).

Earlier this week, Community Pharmacy Scotland (CPS) accepted the Scottish government’s initial financial offer for the 2025/26 fiscal year, securing a guaranteed minimum reimbursement of £120 million for community pharmacies — up from £110 million from 2024/25.

Keep ReadingShow less
GP surgery upgrades for annual appointments

The surgeries will have additional space to “see more patients, boost productivity and improve patient care”

Pic credit: iStock

GP surgery upgrades to create 8.3 million more annual appointments

Over 1,000 GP surgeries will have their premises modernised to meet the needs of a further 8.3 million appointments each year, the government has announced.

Backed by a cash injection of over £102 million, the surgeries will have additional space to “see more patients, boost productivity and improve patient care”.

Keep ReadingShow less
Wales boosts funding for pharmacy-led UTI and sore throat test services

The sore throat test (STTT) and treat service will be widely available

Pic credit: istock

Welsh pharmacies receive funding boost for clinical services

Two key clinical services will be available in 99 per cent of community pharmacies across Wales after a boost in funding.

The sore throat test (STTT) and treat service and the urinary tract infection (UTI) service have both benefitted from contractual negotiations between the Welsh Government and Community Pharmacy Wales (CPW).

Keep ReadingShow less