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List of Field Safety Notices (FSNs) from 19 to 23 December 2022.
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Galderma (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in some batches of Epiduo 0.1% / 2.5% gel contain outdated safety information regarding pregnancy.
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Galderma (U.K.) Limited has informed the MHRA that the patient information leaflet (PIL) packaged in specific batches of Etrivex Shampoo is missing safety information
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List of Field Safety Notices (FSNs) from 28 November to 2 December 2022
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ADVANZ PHARMA has made the MHRA aware that certain batches of MacroBID 100mg Prolonged-Release Capsules have been packed with the incorrect Patient Information Leaflet (PIL).
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Lucis Pharma Ltd has informed the MHRA that there is a typographical error with text on the rear side of the outer packaging for Oxycodone Hydrochloride 10mg/ml Oral Solution.
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List of Field Safety Notices (FSNs) from 21 to 25 November 2022
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List of Field Safety Notices (FSNs) from 14 to 18 November 2022
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Morningside Healthcare Limited has informed the MHRA of an error with the Patient Information Leaflet (PIL) packaged in batch 22237001 of Hyoscine Butylbromide 20 mg Film-coated Tablets.
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Martindale Pharma has made the MHRA aware that the GTIN in the 2D barcode and the printed variable
data represents the branded version of the product (Venlalic® XL 300 mg prolonged-release tablets).
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List of Field Safety Notices (FSNs) from 7 to 11 November 2022
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Macarthys Laboratories (trading as Martindale Pharma, an Ethypharm Group Company), has notified the MHRA of a limited number of Prenoxad packs in a batch marketed in France with missing needles.
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List of Field Safety Notices (FSNs) from 31 October to 4 November 2022
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List of Field Safety Notices (FSNs) from 24 to 28 October 2022
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Medreich PLC UK is recalling a batch of Mebeverine hydrochloride 135mg film-coated tablets as a precautionary measure due to out of specification results for tablet dissolution during routine product release testing.
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Recordati Rare Diseases T/A Recordati Rare Diseases UK Ltd has made the MHRA aware that specific batches of Pedea 5 mg/ml solution for injection have been packaged with the incorrect Product Information Leaflet (PIL).
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List of Field Safety Notices (FSNs) from 17 to 21 October 2022
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Sanofi UK is initiating an urgent recall of two batches of Targocid 200mg powder for solution for injection/infusion or oral solution
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hameln pharma ltd is initiating a recall of the affected batches of Ephedrine Hydrochloride 30 mg/ml Solution for Injection as a precautionary measure.
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List of Field Safety Notices (FSNs) from 10 to 14 October 2022
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List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 December 2019.
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Flamingo Pharma UK Ltd has identified an error relating to the ink printing of the batch number and expiry date on the carton for three batches of Ibuprofen 400mg Tablets. This notification includes all potentially impacted …
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List of field safety notices (FSNs) from medical device manufacturers from 04 to 08 October 2021
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hameln pharma ltd is initiating a recall of batch 210505 of Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion as a precautionary measure
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Summary list of field safety notices (FSNs) from medical device manufacturers from 24 August to 28 August 2020.
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List of field safety notices for week 03 to 07 October 2022
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Sanofi is recalling all batches of Stemetil 5mg/5ml Syrup as a precautionary measure due to the identification of N-nitrosomethylphenylamine (NMPA) above the acceptable limit.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 September 2022.
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Summary List of field safety notices (FSNs) from medical device manufacturers from `9 to 23 September 2022.
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Venous and arterial pressure limits may be altered unintentionally following acknowledgement of the alarm in some haemodialysis and haemofiltration machines. If the cause of the alarm is not addressed, the machine may not re…
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Summary List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 September 2022
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Novartis Pharmaceuticals UK are recalling a batch of Sandimmun Oral Solution due to the presence of crystals in the solution.
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Rosemont Pharmaceuticals Ltd. has made the MHRA aware that the expiry dates stamped on the base of the bottle are incorrect for 2 batches of Atorvastatin 4mg/ml Oral Suspension and 2 batches of Sildenafil 10mg/ml Oral Suspen…
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Summary List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 September 2022
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Quadrant Pharmaceuticals Limited have informed the MHRA of an error with the Patient Information Leaflets (PILs) that have been packaged in various parallel imported batches.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 29 August to 2 September 2022.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 22 to 26 August 2022
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Hikma Pharmaceuticals USA Inc are recalling the below batches due to an out of specification result with related substances during testing for retain samples.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 August 2022.
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The UK Marketing Authorisation Holder has confirmed that a batch of Dysport 500 Units Powder for Solution for Injection is falsified and has been supplied by unauthorised distributors to the UK.
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Accord Healthcare have informed us of an error with the patient information leaflets (PILs) that have been packaged in some Rosuvastatin products.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 August 2022.
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List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 October 2021
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Sun Pharmaceuticals are recalling batches of zoledronic acid due to out of specification results observed for Particulate Matter Test during routine stability testing.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 1 to 5 August 2022.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 July 2022.
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Stockport Pharmaceuticals are recalling a batch of Sodium Chloride Eye Drops 5% w/v as the sterile eye droppers supplied with the medicinal product have expired (January 2022).
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Clinigen Healthcare Ltd is initiating a recall of three batches of Mexiletine hydrochloride hard capsules due to a potential risk of underdose or overdose, which could have consequences for the safety of patients.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 July 2022.
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Philips Health Systems have identified an important safety issue due to potential unexpected shutdowns of all of their V60 and V60 Plus non-invasive ventilators. All V680 invasive ventilators used in critical care settings …