National Patient Safety Alert: Recall of Mexiletine hydrochloride Capsules, Clinigen Healthcare Ltd

Recall of three batches of Mexiletine hydrochloride hard capsules due to a potential risk of under or overdose, which could have consequences for the safety of patients

Batches affected are:

 

Batch Number

Expiry Date

Pack Size

First Distributed

Mexiletine hydrochloride 50mg Hard Capsules – PL 31644/0027

2111216

02/2024

84

10/02/2022

Mexiletine hydrochloride 100mg Hard Capsules – PL 31644/0028

2111217

04/2024

84

10/02/2022

Mexiletine hydrochloride 200mg Hard Capsules – PL 31644/0029

2111218

04/2024

100

10/02/2022

Stability testing has identified that some capsules may fall outside the individual fill-weight range. This means that there is the potential for some capsules to contain too little active ingredient and for some to contain too much active ingredient. This could result in potential underdosing and overdosing.

Clinigen Healthcare Ltd has confirmed that no alternative stock will be available until later in the year, therefore the recall from patients should only be considered where there is alternative products.

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

Actions required – to complete by 12 August 2022

  1. Stop supplying the impacted batch immediately. Quarantine all remaining stock and return it to your supplier/MAH using your supplier’s approved process.
  2. Identify any patients who have been dispensed the impacted batch (assume all patients dispensed this product since 10 February 2022).
  3. If any patients are identified, contact the patient’s GP and discuss alternative mexiletine treatment of the patient.
  4. 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.

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