MHRA Drug & Device Safety Alerts
Drug safety updates, medicines recalls, device safety information and field safety notices published by the Medicines and Healthcare products Regulatory Agency. Source: MHRA alerts and recalls on GOV.UK.
Field Safety Notice - 14 to 18 August 2017
A weekly index of the field safety notices manufacturers issued that week.
Field Safety Notice - 21 to 25 August 2017
A weekly index of the field safety notices manufacturers issued that week.
Shoulder system: Comprehensive Nano Humeral Components – increased risk of revision when used in reverse configuration
DePuy Synthes Impactor for PFNA (Proximal Femoral Nail Anti-rotation) Blade: risk of infection
Letters sent to healthcare professionals in July 2017
A periodic index page listing other alerts and letters, not a single alert.
Medical Device Alerts issued in July 2017
A periodic index page listing other alerts and letters, not a single alert.
Corticosteroids: rare risk of central serous chorioretinopathy with local as well as systemic administration
An article in MHRA's monthly Drug Safety Update bulletin.
Ibrutinib (Imbruvica▼): reports of ventricular tachyarrhythmia; risk of hepatitis B reactivation and of opportunistic infections
An article in MHRA's monthly Drug Safety Update bulletin.
Adrenaline auto-injectors: updated advice after European review
An article in MHRA's monthly Drug Safety Update bulletin.
Field Safety Notice - 07 to 11 August
A weekly index of the field safety notices manufacturers issued that week.
Field Safety Notice - 31 July to 4 August 2017
A weekly index of the field safety notices manufacturers issued that week.
Field Safety Notice - 24 to 28 July 2017
A weekly index of the field safety notices manufacturers issued that week.
Class 3 Medicines Recall: Specific batches of Torrent Dutor (Duloxetine) Gastro-resistant Capsules
MHRA class: the defect is unlikely to cause harm; recall is on other grounds.
Field Safety Notice - 17 to 21 July 2017
A weekly index of the field safety notices manufacturers issued that week.
Daclizumab (Zinbryta▼) and risk of severe liver injury: initiation in multiple sclerosis now restricted, promptly review patients already on treatment
An article in MHRA's monthly Drug Safety Update bulletin.
Bendamustine (Levact): increased mortality observed in recent clinical studies in off-label use; monitor for opportunistic infections, hepatitis B reactivation
An article in MHRA's monthly Drug Safety Update bulletin.
Nivolumab (Opdivo▼), pembrolizumab (Keytruda▼): reports of organ transplant rejection
An article in MHRA's monthly Drug Safety Update bulletin.
Letters sent to healthcare professionals in June 2017
A periodic index page listing other alerts and letters, not a single alert.
Medical Device Alerts issued in June 2017
A periodic index page listing other alerts and letters, not a single alert.
Field Safety Notice - 3 to 7 July 2017
A weekly index of the field safety notices manufacturers issued that week.
Field Safety Notice - 10 to 14 July 2017
A weekly index of the field safety notices manufacturers issued that week.
Sodium Chloride Infusion 0.9% w/v 1000 mL bags
Haemofiltration machine: all Prismaflex systems installed with software version 6.10 – risk of under-infusion of anticoagulant
Field Safety Notice - 26 to 30 June 2017
A weekly index of the field safety notices manufacturers issued that week.
Parallel Imported One-Alpha Drops x 10 ml - Pharmacy and wholesaler level recall of two batches
All metal-on-metal (MoM) hip replacements: updated advice for follow-up of patients
Field Safety Notice - 19 to 23 June 2017
A weekly index of the field safety notices manufacturers issued that week.
Letters sent to healthcare professionals in May 2017
A periodic index page listing other alerts and letters, not a single alert.
e-cigarettes and refill containers (e-liquids): report suspected side effects and safety concerns
An article in MHRA's monthly Drug Safety Update bulletin.
Denosumab (Prolia, Xgeva▼): reports of osteonecrosis of the external auditory canal
An article in MHRA's monthly Drug Safety Update bulletin.
Medical Device Alerts issued in May 2017
A periodic index page listing other alerts and letters, not a single alert.
Brimonidine gel (Mirvaso): risk of systemic cardiovascular effects; not to be applied to damaged skin
An article in MHRA's monthly Drug Safety Update bulletin.
Pseudoephedrine and ephedrine: regular review of minimising risk of misuse in the UK
An article in MHRA's monthly Drug Safety Update bulletin.
Field Safety Notice - 12 to 16 June 2017
A weekly index of the field safety notices manufacturers issued that week.
Field Safety Notice - 5 to 9 June 2017
A weekly index of the field safety notices manufacturers issued that week.
DePuy Synthes Radial Head elbow prosthesis system: risk of post-operative loosening of the radial stem
Field Safety Notice - 29 may to 2 June 2017
A weekly index of the field safety notices manufacturers issued that week.
Field Safety Notices - 22 - 26 May 2017
A weekly index of the field safety notices manufacturers issued that week.
Letters sent to healthcare professionals in April 2017, including a reminder of the retigabine (Trobalt) withdrawal
A periodic index page listing other alerts and letters, not a single alert.
Finasteride: rare reports of depression and suicidal thoughts
An article in MHRA's monthly Drug Safety Update bulletin.
All HeartStart MRx defibrillators – possible failure to deliver a shock, cardioversion, pacing or monitoring
New CPD e-learning module on reporting suspected adverse drug reactions
An article in MHRA's monthly Drug Safety Update bulletin.
Field Safety Notice - 15 to 19 May 2017
A weekly index of the field safety notices manufacturers issued that week.
Class 2 Medicines Recall: Sodium Cromoglicate 2% w/v 13.5 mL Eye Drops
MHRA class: the defect could cause illness or mistreatment, but is not Class 1.
All LIFEPAK 1000 automatic external defibrillators (AEDs) - risk of device shutting down unexpectedly during patient treatment and possible failure to deliver therapy
Field Safety Notice - 8 to 12 May 2017
A weekly index of the field safety notices manufacturers issued that week.
Field Safety Notice - 1 May to 5 May 2017
A weekly index of the field safety notices manufacturers issued that week.
Biological replacement pericardial aortic heart valve: Mitroflow LX (sizes 19mm and 21mm) – risk of early structural valve deterioration
All Accu-Chek® Insight insulin pumps – updated information for battery management
About this source
Read the chart values
| Alert type | Individual alerts |
|---|---|
| Drug Safety Update | 713 |
| Class 1 Medicines Recall | 6 |
| Class 2 Medicines Recall | 159 |
| Class 3 Medicines Recall | 68 |
| Class 4 Medicines Defect Information | 179 |
| Company-Led Medicines Recall | 35 |
| Device Safety Information | 21 |
| Medical Device Alert | 40 |
| National Patient Safety Alert | 11 |
| MHRA Safety Roundup | 16 |
| Unclassified | 253 |
The MHRA regulates medicines and medical devices in the UK and publishes safety communications on GOV.UK in two streams: the monthly Drug Safety Update bulletin, and Alerts and recalls for drugs and medical devices. This page holds 2,267 of those publications, issued between October 2009 and July 2026.
MHRA classes a medicines recall by the hazard the defect presents: Class 1 life-threatening or serious, Class 2 could cause illness or mistreatment, Class 3 unlikely to cause harm, and Class 4 a caution in use rather than a recall, with the product staying available. A device notice is published as Device Safety Information, or, until 2021, as a Medical Device Alert.
What is not here. We hold each publication's title, type, date and link, not its text: read the alert on GOV.UK for the affected products and the actions MHRA asks for. An alert names a medicine or device and a clinical audience, not an organisation, so no alert on this page is linked to an NHS trust or other responsible body. The weekly “Field Safety Notices” pages are MHRA's own index of the notices manufacturers issued that week, not single alerts, and are counted separately above.