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Drug Alerts and Withdrawals

Drug Alerts and Withdrawals

Within the UK, the Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency of the Department of Health aim to enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe. No product is risk-free. Underpinning their work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks.

  • The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.
  • No product is risk-free. Underpinning the work of the MHRA lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks.
  • The MHRA keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem.
  • The MHRA aim to make as much information as possible publicly available. The MHRA enable greater access to products, and the timely introduction of innovative treatments and technologies that benefit patients and the public.
  • The MHRA encourage everyone - the public and healthcare professionals as well as industry - to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. To find out more about the MHRA click here...

When the MHRA, or occasionally another regulatory body in another country, such as the FDA, release advice, it is sometime necessary to produce additional local guidance.  This aims to be both clear and concise advice to healthcare professionals on the local action required to implement or respond to alerts issued by the MHRA or other bodies.  These memorandums are available below for reference, once they have been circulated to the relevant professionals in primary and secondary care:

MHRA News Stories.

 26th July 2019              MHRA News Story - MHRA takes action to ensure product safety for patients supplied with total parenteral
                                                                          nutrition bags from the Calea UK/Fresenius Kabi manufacturing facility in Runcorn
 25th July 2019              MHRA Press Release - Patients to check if they have certain prescription-only medicines as additional products 
 28th June 2019            MHRA Press Release - Patient to check if they have prescription-only medicines being recalled
 13th June 2019            Yellow Card: Please help reverse the decline in reporting of suspected adverse drug reactions
 12th February 2019    MHRA Press release - Additional blood pressure and heart  medication recalled from pharmacies
 24th January 2019      MHRA Press release- MHRA recalls more blood pressure & heart medication from pharmacies as a precaution

MHRA Company-led Drug alerts

click here to access the most recent alerts

Items In This Category

application/pdfAripiprazole 1mg per ml oral soln_class 2 meds recall 0719.pdf (147KB)31/07/2019Download
 Accord-UK Ltd is recalling the above batches due to the potential for small particles of Aripiprazole active material to be present which may affect the efficacy of the product. No relevant product... 
application/pdfBisacodyl 5mg GR tabs_Chanelle Medical Class 2 meds recall 0719_Final.pdf (191KB)31/07/2019Download
 Chanelle Medical is recalling the above batch because a small number of packs have been found to contain tablets which are stuck together, with mould observed on some tablets. The mould has been... 
application/pdfPhenobarbital sod 30mg permL injection Cl 4 meds defect info EL__19__A_16_Final_.pdf (181KB)08/07/2019Download
 phenobarb, elixir 
application/pdfMHRA FMD Alert B&S Healthcare 0619 EL__19_A15_final_.pdf (249KB)28/06/2019Download
 Falsified medicines have entered the UK supply chain at pharmacy and patient level. The products have been parallel imported into the UK by B & S Healthcare from Italy and have been re-labelled or... 
application/pdfParacetamol 500mg tabs 1x1000 M&A Pharma MHRA Class 2 medicines recall 130619.pdf (113KB)13/06/2019Download
 M & A Pharmachem is recalling the above batches because a small number of pots from each batch have been found to contain discoloured tablets due to fungal contamination. The fungi have been... 
application/pdfPotassium Chloride_Baxter_iv infusions Class 4 Drug Alert 030619.pdf (624KB)03/06/2019Download
 Baxter Healthcare have identified a quality defect with products included in this drug alert. 
application/pdfCo-amoxiclav susp 125 & 250mg May 2019 Sandoz Class 2 meds recall.pdf (67KB)14/05/2019Download
 Sandoz Ltd. have been notified of a potential packaging problem relating to poor seal adherence which could cause clumping of the powder within the bottle. A poor bottle seal could lead to... 
application/pdfPrednisolone tablets class 4 medicines defect info MHRA_EL__19_A_11.pdf (162KB)26/04/2019Download
 Genesis Pharmaceuticals Ltd has informed us that there is an error on the Braille for the above batches which means that the strength reads as 1mg instead of 5mg. The printed text is correct on all... 
application/pdfAtivan 4mg in 1mL sol for inj Class 4 Meds recall EL19A10Final.pdf (145KB)25/04/2019Download
application/pdfZoledronic_acid_solution_for_infusion_Drug_Alert.pdf (157KB)05/04/2019Download
 Ranbaxy (UK) Ltd a Sun Pharmaceutical Company, has informed us that some packs from the above batch contain a Patient Information Leaflet (PIL) for Temozolomide 180mg Capsules. 
application/pdfLosartan Potassium 50mg 100mg class 2 medicines recal Accord March 2019EL__19_A07_Final.pdf (144KB)25/03/2019Download
 losartan, accord, recall, drug, safety 
application/pdfOzurdex Intravitreal Implant in Applicator recall Allergan UK_Final_-DHPC_180319.pdf (69KB)18/03/2019Download
 Allergan Pharmaceuticals Ireland is further recalling batches due to the possibility that a single loose silicone particle of approximately 300 microns in diameter may become detached.  
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