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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.

 4th March 2020            MHRA Press Release - Patients asked to return Emerade 150 micrograms adrenaline pens
 24th February 2020     MHRA Guidance - Coronavirus (COVID-19): latest information and advice
12th February 2020      MHRA Press Release  - Integrated Yellow Card reporting now available in 93% of GP practices in the UK
19th November 2019   MHRA Press Release - Ranitidine Oral Solution & Tablets recall
26th September 2019  MHRA Press Release - Contact lenses recall: 1-day Acuvue mMoist for Astigmatism
23rd September 2019  MHRA Press Release - Two benzoyl peroxide products to treat mild acne affecting the face to go on general sale
19th September 2019  MHRA Update - Update on licensing status of Avastin when intended for intravitreal administration
30th August 2019         MHRA Update - HRT users to discuss its risks and benefits at their next routine appointment as new study
                                                                   highlights persistent risk of breast cancer
1st August 2019           MHRA Update -  First Allergy Test for hair dye to go on general sale
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


MHRA Company-led Drug alerts

click here to access the most recent alerts

Items In This Category

 TitleCreatedDownload
application/pdfOzurdex 700mcg intravitreal implant in applicator Class 2 medicines recall MHRA Final 0518.pdf (262KB)05/10/2018Download
 Allergan Pharmaceuticals Ireland is recalling some batches in the attached alert due to the possibility that a single loose silicone particle of approximately 300microns in diameter may become... 
application/pdfSodium Cromoglicate & Murine hayfever relief eye drops Class 3 medicines recall EL_18_A13-Final.pdf (132KB)31/07/2018Download
 FDC International Ltd is recalling the above batches due to the presence of a precipitate, which has been identified as Sodium Cromoglicate, in some bottles. 
application/pdfValsartan Class 1 medicines recall EL_18_A_11-_revision_1.pdf (62KB)11/07/2018Download
 The Drug Alert EL (18)A/11 issued on 5 July 2018 is now superseded by this revised alert EL (18)A/11 – revision 1 because Actavis (now Accord) has provided new information that an additional product... 
application/pdfFiasp FlexTouch 100units per mL class 2 medicines recall 090718.pdf (31KB)09/07/2018Download
 Novo Nordisk is recalling one batch as a precautionary measure due to the presence of particles in a small number of samples. 
application/pdfValsartan Class 1 Medicines Recall ACTION NOW 050718 EL_18_A_11.pdf (62KB)06/07/2018Download
 Valsartan Class 1 Medicines Recall ACTION NOW Pharmacies in the UK are being advised to recall all batches of valsartan containing medicines made by Dexcel Pharma Ltd and Accord Healthcare... 
application/pdfInhixa sol for injection Class 4 medicines recall april 2018.pdf (263KB)27/04/2018Download
 Inhixa soln for injection. Class 4 medicines defect information april 2018 
application/pdfLynparza Class 3 MEDICINES RECALL 120318_astra zeneca.pdf (135KB)12/03/2018Download
 AstraZeneca is recalling batch NG327 as the level of olaparib polymorphic form L exceeds the registered specification limit. As a precautionary measure additional batches are also being recalled... 
application/pdfVentolin Accuhaler Class 2 Medicines recall 0218 EL_18_A03-Final.pdf (436KB)22/02/2018Download
 Glaxo Wellcome UK Limited is recalling Lots 786G and 754P of Ventolin Accuhaler 200mcg because a manufacturing issue with these Lots has been identified which has resulted in a small number of units... 
application/pdfSeretide Accuhaler Class 2 Medicines recall 0218_EL(18)A_04.pdf (290KB)22/02/2018Download
 Glaxo Wellcome UK Limited is recalling LOT 5K8W of Seretide Accuhaler 50/250mcg because a manufacturing issue with this Lot has been identified which has resulted in a small number of units not... 
application/pdfEsmya _ulipristal_ uterine fibroids -MHRA letter February 2018.pdf (62KB)15/02/2018Download
  
application/pdfMagnevist and Omniscan sol for inj_class 2 medicines recall MHRA.pdf (153KB)02/02/2018Download
 All unexpired stock of the above products marketed by Bayer plc and GE Healthcare AS is being recalled and should immediately be quarantined. This follows a safety review of the gadolinium EL (18)... 
application/pdfMolipaxin 100mg capsules Class 2 medicines recall.pdf (229KB)04/01/2018Download
 A precautionary recall is being carried out due to the potential that during manufacture of the batch, the metal detector may not have functioned and therefore that the presence of metal particles... 
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