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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/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.  
application/pdfAtropine Sulfate 3mg per 10ml Soln for injection in pfs EL 19 A05 Final.pdf (151KB)18/02/2019Download
 Aguettant Limited has informed the MHRA that there is an error in the Patient Information Leaflet (PIL) for batches of the above product listed above. In Section 6 of the Leaflet included in these... 
application/pdfIrbesartan Class 2 medicines recall Actavis Group EL_19_A04-Final.pdf (163KB)14/02/2019Download
  
application/pdfIrbesartan 150mg Class 2 medicines recal EL__19_A02_Final.pdf (164KB)24/01/2019Download
 Macleods Pharma UK Limited is recalling the above batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA). 
application/pdfIrbesartan hydrochlorothiazide Class 2 medicines recall MHRA.pdf (163KB)03/01/2019Download
 Class 2 Medicines Recall: Actavis Group PTC EHF – recall of batches of Irbesartan/Hydrochlorothiazide 300/12.5mg Film-coated Tablets and Irbesartan/Hydrochlorothiazide 150/12.5mg Film-coated Tablets 
application/pdfLidocaine teething products: talk to your pharmacist -patient-sheet.pdf (88KB)13/12/2018Download
 Key messages for parents and caregivers 
application/pdfValsartan Class 2 medicines recall 301118 MHRA.pdf (167KB)30/11/2018Download
 Teva is recalling the listed batches and Mylan is recalling all unexpired batches of the above products from pharmacies as a precautionary measure at a European level due to possible contamination... 
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