Letters and medicine recalls sent to healthcare professionals in July 2022
A summary of recent letters and notifications sent to healthcare professionals about medicines, and a patient safety alert on mexiletine hydrochloride.
National Patient Safety Alert on the recall of 3 batches of mexiletine hydrochloride (50mg, 100mg and 200mg hard capsules)
On 4 August 2022, we issued a National Patient Safety Alert to support the recall of 3 batches of Mexiletine hydrochloride hard capsules by manufacturer Clinigen Healthcare Ltd. This recall is due to a potential risk of underdose or overdose that could have consequences for the safety of patients.
Clinigen Healthcare Limited 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.
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.
For more information, please see the National Patient Safety Alert page.
Letters
In July 2022, the following letters were sent or provided to relevant healthcare professionals:
- (updated 14 September 2022)
Gina 10 microgram vaginal tablets (estradiol): reclassification to a pharmacy medicine product available without prescription
Gina 10 microgram vaginal tablets (containing estradiol hemihydrate) are used for the treatment for the treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women aged 50 years and above, who have not had a period for at least 1 year.
Following advice from the Commission on Human Medicines and careful consideration of the response to consultation, the MHRA has approved the pharmacy (P) legal status for Gina 10 microgram vaginal tablets. A Public Assessment Report has been made available.
For more information, please see the pharmacy training materials containing a pharmacy guide and a checklist.
Medicine Recalls and Notifications
In July 2022, recalls and notifications for medicines were issued on:
Class 4 Medicines Defect Information: Thornton & Ross, Covonia Night Time Formula and Covonia Original Bronchial Balsam, EL(22)A/30. Issued 14 July 2022. Batches of Covonia Night Time Formula (dextromethorphan hydrobromide, diphenhydramine hydrochloride) and Covonia Original Bronchial Balsam (dextromethorphan hydrobromide, menthol) have been identified omitting the ‘P’ symbol for pharmacy medicine on the bottle. This packaging error does not affect product quality and affected products have only been distributed to pharmacies. Healthcare professionals are advised to manage the supply of the above batches in line with the legal requirements for Pharmacy medicines.
Class 2 Medicines Recall: hameln pharma ltd, Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion, EL(22)A/31. Issued 19 July 2022. A batch of amiodarone hydrochloride 50 mg/ml concentrate for solution for injection/infusion is being recalled due to increased presence of visible crystalline particles within the solution. This recall is a precaution as the potential for amiodarone solutions for injection/infusion to crystallise with associated potential for amiodarone-induced phlebitis is known. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
Class 4 Medicines Defect Information: Omega Pharma Limited, Niquitin 14mg Clear Patch (14 patches), EL(22)A/32. Issued 20 July 2022. Two batches of Niquitin 14mg Clear Patch (nicotine) have been identified with a packaging error. Affected packs incorrectly states the patches contain 21mg of nicotine instead of the correct 14mg. Healthcare professionals and other retailers are advised to note the error relating to the product packaging and refer to the dose on the other areas of the carton or sachet which remains correct.
Class 4 Medicines Defect Information: Novo Nordisk Limited, NovoRapid FlexTouch 100 units/ml, Saxenda FlexTouch (liraglutide) 6mg/ml, EL(22)A/33. Issued 21 July 2022. A defect has been identified with a small number of products in batches of NovoRapid FlexTouch (insulin aspart) 100 units/ml solution for injection in pre-filled pen and Saxenda FlexTouch (liraglutide) 6mg/ml Solution for injection in pre-filled pen. The affected pre-filled pens have a defective dose selectors, no click sound will be heard, and as the dose cannot be selected the pen will not inject. The average number of affected products is 2 to 3 pens per million. Healthcare professionals are advised to follow the usual safety and complaints process to issue replacement pens, and to advise patients to always carry a spare pen.
For all of the latest safety notices from the MHRA on drugs and medical devices, see Alerts and recalls for drugs and medical devices.
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Article citation: Drug Safety Update volume 16, issue 1: August 2022: 3.