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Written by AlisonFreemantle on Friday 5th August 2022
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:
Mexiletine hydrochloride 50mg Hard Capsules – PL 31644/0027
Mexiletine hydrochloride 100mg Hard Capsules – PL 31644/0028
Mexiletine hydrochloride 200mg Hard Capsules – PL 31644/0029
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
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