If you, or anyone you know or care for, takes Mexiletine, please follow the link and act appropriately.
National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Mexiletine hydrochloride 50mg, 100mg and 200 mg Hard Capsules, Clinigen Healthcare Ltd, due to a potential for underdosing and/or overdosing, NatPSA/2022/007/MHRA
Clinigen Healthcare Ltd is initiating a recall of three batches of Mexiletine hydrochloride hard capsules due to a potential risk of underdose or overdose, which could have consequences for the safety of patients.
From:
Medicines and Healthcare products Regulatory Agency
Published
4 August 2022
Last updated
4 August 2022 — See all updates
This alert is for action by: primary and secondary care, specifically those involved in pharmacy services, including dispensing general practices.
🔴 This is a safety critical and complex National Patient Safety Alert. Implementation should be coordinated by an executive leader (or equivalent role in organisations without executive boards) supported by Chief Pharmacists and the clinical lead for cardiology, as well as leaders in general practice and community pharmacy.
National Patient Safety Alert Reference Number
NatPSA/2022/007/MHRA
PL Number
Mexiletine hydrochloride 50mg Hard Capsules, PL 31644/0027
Mexiletine hydrochloride 100mg Hard Capsules, PL 31644/0028
Mexiletine hydrochloride 200mg Hard Capsules, PL 31644/0029
There is much more information in the full recall alert, including specific Advice for patients, which is available here:
