Alerts, recalls and safety information: drugs and medical devices

National Patient Safety Alert: Reducing risks for transfusion-associated circulatory overload (NatPSA/2024/004/MHRA)

TACO is one of the most common causes of transfusion-related deaths in the UK and cases have increased substantially in recent years. Identifying risk factors for TACO prior to transfusion allows initiation of appropriate mi…

Alert type: National patient safety alert
Issued: 4 April 2024

National Patient Safety Alert: Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients (NatPSA/2023/013/MHRA)

The MHRA is asking organisations to put a plan in place to implement new regulatory measures for sodium valproate, valproic acid and valproate semisodium (valproate). This follows a comprehensive review of safety data, advic…

Alert type: National patient safety alert
Issued: 28 November 2023

National Patient Safety Alert: Medical beds, trolleys, bed rails, bed grab handles and lateral turning devices: risk of death from entrapment or falls (NatPSA/2023/010/MHRA)

The MHRA continues to receive reports of deaths and serious injuries from entrapment or falls relating to medical beds, bed rails, trolleys, bariatric beds, lateral turning devices and bed grab handles.

Alert type: National patient safety alert
Medical specialism: Cardiology and 17 others
Issued: 30 August 2023

National Patient Safety Alert: Potential risk of underdosing with calcium gluconate in severe hyperkalaemia (NatPSA/2023/007/MHRA)

This alert highlights the Adult Renal Association Clinical Practice Guidelines (2020) recommendation on calcium gluconate use to support organisations to update local policies and guidelines for the treatment of severe hyper…

Alert type: National patient safety alert
Medical specialism: Cardiology and 2 others
Issued: 27 June 2023

National Patient Safety Alert: Removal of Philips Health Systems V60 and V60 Plus ventilators from service: risk of shutdown leading to complete loss of ventilation (NatPSA/2023/005/MHRA)

The MHRA is issuing updated advice that Philips Respironics V60 and V60 Plus non-invasive ventilators must be permanently removed from use.

Alert type: National patient safety alert
Medical specialism: Anaesthetics and 2 others
Issued: 18 May 2023

National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors, due to the potential for device failure, NatPSA/2023/004/MHRA

Pharmaswiss Česka republika s.r.o. is initiating an urgent recall of all batches of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors.

Alert type: National patient safety alert
Medical specialism: Anaesthetics and 22 others
Issued: 9 May 2023

National Patient Safety Alert: NIDEK EyeCee One preloaded and EyeCee One Crystal preloaded Intraocular Lenses (IOLs): risk of increased intraocular pressure (NatPSA/2023/003/MHRA)

The MHRA is aware of cases of increased intraocular pressure in patients recently implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs), which are manufactured by NIDEK and distribute…

Alert type: National patient safety alert
Medical specialism: Ophthalmology
Issued: 1 February 2023

National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Targocid 200mg powder for solution for injection/infusion or oral solution, Aventis Pharma Limited t/a Sanofi, due to the presence of bacterial endotoxins, NatPSA/2022/008/MHRA

Sanofi UK is initiating an urgent recall of two batches of Targocid 200mg powder for solution for injection/infusion or oral solution

Alert type: National patient safety alert
Medical specialism: Anaesthetics and 22 others
Issued: 21 October 2022

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.

Alert type: National patient safety alert
Medical specialism: Anaesthetics and 22 others
Issued: 4 August 2022

National Patient Safety Alert: Philips Health Systems V60, V60 Plus and V680 ventilators: potential unexpected shutdown leading to complete loss of ventilation (NatPSA/2022/002/MHRA)

Philips Health Systems have identified an important safety issue due to potential unexpected shutdowns of all of their V60 and V60 Plus non-invasive ventilators. All V680 invasive ventilators used in critical care settings …

Alert type: National patient safety alert
Medical specialism: Anaesthetics and 2 others
Issued: 29 March 2022

National Patient Safety Alert: NovoRapid PumpCart in the Roche Accu-Chek Insight insulin pump: risk of insulin leakage causing hyperglycaemia and diabetic ketoacidosis (NatPSA/2022/004/MHRA)

The MHRA continues to receive serious reports of harm associated with insulin leakage for the NovoRapid PumpCart prefilled insulin cartridge in the Accu-Chek Insight Insulin pump. In some patients, there were serious consequ…

Alert type: National patient safety alert
Medical specialism: Dispensing GP practices and 3 others
Issued: 26 May 2022

National Patient Safety Alert: Philips ventilator, CPAP and BiPAP devices: Potential for patient harm due to inhalation of particles and volatile organic compounds (NatPSA/2021/005/MHRA)

Philips have issued 2 FSNs about selected ventilators and CPAP and BiPAP devices.

Alert type: National patient safety alert
Medical specialism: Anaesthetics and 5 others
Issued: 23 June 2021

National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Co-codamol 30/500 Effervescent Tablets, Batch 1K10121, Zentiva Pharma UK Ltd, due to precautionary risk of causing overdose, NatPSA/2021/004/MHRA

Zentiva Pharma UK Limited is recalling the above batch of Co-codamol 30/500 Effervescent Tablets as a precautionary measure due to an issue with the homogeneity of the batch. This issue means that there is the potential for …

Alert type: National patient safety alert
Medical specialism: Anaesthetics and 21 others
Issued: 16 June 2021

National Patient Safety Alert: Supply disruption of sterile infusion sets and connectors manufactured by Becton Dickinson (BD) (NatPSA/2021/001/MHRA)

BD have notified the MHRA that the sterility of some of their devices cannot be guaranteed due to quality issues with their third-party sterilisation provider.

Alert type: National patient safety alert
Medical specialism: Anaesthetics and 21 others
Issued: 11 March 2021

National Patient Safety Alert: Philips Respironics V60 ventilator - unexpected shutdown (NatPSA/2020/007/MHRA)

Actions to be taken to avoid potential unexpected shutdown leading to complete loss of ventilation

Alert type: National patient safety alert
Medical specialism: Critical care
Issued: 23 September 2020

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