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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

Ibuprofen 400mg Class 4 Medicines recallEL__20_A_10_FInal__002_.pdf

Ibuprofen 400mg Class 4 Medicines recallEL__20_A_10_FInal__002_.pdf
Summary: Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd have informed us that the Patient Information Leaflet (PIL) within their packs for the above pharmacy (P) batches is incorrect. The PIL in the above batches includes incorrect dosing instructions in Section 3, How to take Ibuprofen. The leaflet incorrectly states that 'The maximum daily dose should not exceed 6 [six] tablets (2400 mg).' This dosing regimen should only be given to patients who are under the supervision of their GP or healthcare pre
File Size: 173KB
File Type: application/pdf
Created: 21 February 2020
Last Modified: 24 February 2020