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B. Braun Medical Ltd is Recalling batches as ongoing stability studies have identified that they may have an out of specification result in the glucose chamber at the end of shelf-life.
Summary List of field safety notices (FSNs) from medical device manufacturers from 30 May - 3 June 2016
(Dextro)propoxyphene can have serious effects on the electrical activity of the heart (resulting in prolongation of the P-R and Q-T intervals, and widened QRS complexes), even at normal therapeutic doses.
Macopharma is recalling certain batches of intravenous infusion bags as a precaution. This is due to the detection of metal particles in two infusion bags.
Guidance has been published about thalidomide, lenalidomide, and pomalidomide and the use of remote consultations and home pregnancy testing for patients taking them during COVID-19.
Medicines have been taken out of the regulated medicines’ supply chain during distribution. The products have been parallel imported into the UK by Kosei Pharma, CST Pharma and Ordinant Medical Solutions from Italy and they have been re-labelled in Kosei...
Gadolinium-containing contrast agents are associated with a varying degree of risk of nephrogenic systemic fibrosis. See advice below to minimise risk in the following vulnerable groups: patients with renal impairment; patients in the perioperative liver transplantation period; infants, neonates, and...
Since November 2014, letters were sent regarding vismodegib (Erivedge ▼), chlorhexidine solutions, carbocisteine oral liquid (Mucodyne Paediatric 125mg/5ml), regadenoson (Rapiscan), a parenteral nutrition emulsion (Triomel), and telavancin (Vibativ▼).
Following observation in a clinical study of an increased risk of pulmonary embolism and overall mortality with tofacitinib 10 mg twice-daily in rheumatoid arthritis, a safety review has started and new contraindications introduced. The 10 mg twice-daily dose of tofacitinib...
Healthcare professionals should report any suspected adverse effects relating to fingolimod (Gilenya▼) or other treatments for multiple sclerosis, including suspected adverse effects occurring after discontinuation, via the Yellow Card Scheme.
Unscrupulous East London health supplements company that secured £128,000 from elderly and vulnerable customers has been shut down by the courts.
Suspension of the licences (marketing authorisations) for Octagam (intravenous human normal immunoglobulin 5% and 10%) lifted.
Products containing doses equal to or greater than 1178mg/day of base glucosamine will now be considered to be medicines.
A European review has begun into the safety of radium-223 dichloride following an observed increase in the incidence of deaths and fractures in patients with chemotherapy-naive metastatic castration-resistant prostate cancer receiving radium-223 dichloride in combination with abiraterone acetate (Zytiga) and...
From October 2014 Dexamethasone 4 mg/ml injection (Organon Laboratories Limited) will be replaced by Dexamethasone 3.8 mg/ml solution for injection (Aspen Pharma Trading Limited).
Sage Products Cooperatief UA: Precautionary recall of five batches due to low risk of microbiological contamination
Monitoring of blood electrolytes is essential in patients coprescribed a potassium-sparing diuretic and an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB) for heart failure.
Solu-Medrone 40 mg may contain trace amounts of milk proteins. Do not use in patients with a known or suspected allergy to cows’ milk.
(Wockhardt UK Limited) Remaining stocks of affected batches should be quarantined and returned to original supplier for credit – class 2 action within 48 hours (EL (13)A/19)
Patient reminder cards about the risk of osteonecrosis of the jaw are being introduced; denosumab 120 mg is now contraindicated in patients with unhealed lesions from dental or oral surgery.
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