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Class 4 Medicines Defect Information: Galderma (U.K.) Limited, Etrivex 500 micrograms/g Shampoo, EL (22)A/51
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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Field Safety Notices: 28 November to 2 December 2022
List of Field Safety Notices (FSNs) from 28 November to 2 December 2022
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Class 4 Medicines Defect Information: ADVANZ PHARMA, MacroBID 100mg Prolonged-Release Capsules, EL (22)A/50
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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Class 4 Medicines Defect Information: Lucis Pharma Ltd, Oxycodone Hydrochloride 10mg/ml oral solution, EL (22)A/49
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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Field Safety Notices: 21 to 25 November 2022
List of Field Safety Notices (FSNs) from 21 to 25 November 2022
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Field Safety Notices: 14 to 18 November 2022
List of Field Safety Notices (FSNs) from 14 to 18 November 2022
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Class 4 Medicines Defect Information: Morningside Healthcare Limited, Hyoscine Butylbromide 20 mg Film-coated Tablets, EL (22)A/48
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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Class 4 Medicines Defect Information: Macarthys Laboratories t/a Martindale Pharma, Venlafaxine XL 300 mg prolonged-release tablets, EL(22)A/47
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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Field Safety Notices: 7 to 11 November 2022
List of Field Safety Notices (FSNs) from 7 to 11 November 2022
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National Patient Safety Alert: Class 4 Medicines Defect Information: Prenoxad 1mg/ml Solution for Injection, Macarthys Laboratories (Aurum Pharmaceuticals Ltd/Ethypharm Group), due to potential missing needles in sealed kits, NatPSA/2022/009/MHRA
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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Field Safety Notices: 31 October to 4 November 2022
List of Field Safety Notices (FSNs) from 31 October to 4 November 2022
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Field Safety Notices: 24 to 28 October 2022
List of Field Safety Notices (FSNs) from 24 to 28 October 2022
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Class 3 Medicines Recall: Medreich PLC, Mebeverine hydrochloride 135mg Film-coated tablets, EL (22)A/46
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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Class 4 Medicines Defect Information: Recordati Rare Diseases, Pedea 5 mg/ml solution for injection, EL(22)A/45
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 (PI…
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Field Safety Notices: 17 to 21 October 2022
List of Field Safety Notices (FSNs) from 17 to 21 October 2022
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National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Targocid 200mg powder for solution for injection/infusion or oral solution, Aventis Pharma Limited t/a Sanofi, due to the presence of bacterial endotoxins, NatPSA/2022/008/MHRA
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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Class 2 Medicines Recall: hameln pharma ltd, Ephedrine Hydrochloride 30 mg/ml Solution for Injection, EL(22)A/44
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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Field Safety Notices: 10 to 14 October 2022
List of Field Safety Notices (FSNs) from 10 to 14 October 2022
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Field Safety Notice: 23 to 27 December 2019
List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 December 2019.
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Class 4 Medicines Defect Information: Flamingo Pharma UK Ltd, Ibuprofen 400mg Tablets, Paracetamol 500mg Tablets (Caplets), EL (22)A/43
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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Field Safety Notices: 04 to 08 October 2021
List of field safety notices (FSNs) from medical device manufacturers from 04 to 08 October 2021
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Class 2 Medicines Recall: hameln pharma ltd, Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion, EL (22)A/42
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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Field Safety Notices: 24 - 28 August 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 24 August to 28 August 2020.
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Field safety notice (FSN) 03 to 07 October
List of field safety notices for week 03 to 07 October 2022
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Class 2 Medicines Recall: Aventis Pharma Limited (t/a Sanofi), Stemetil 5mg/5ml Syrup, EL(22)A/41
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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Field Safety Notices: 26 to 30 September 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 September 2022.
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Field Safety Notices: 19 to 23 September 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from `9 to 23 September 2022.
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Haemodialysis and haemofiltration machines: Actions to take following pressure-related alarms to avoid unintentional alteration of alarm limits DSI/2022/004
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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Field Safety Notices: 12 to 16 September 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 September 2022
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Class 2 Medicines Recall: Novartis Pharmaceuticals UK, Sandimmun Oral Solution, EL(22)A/40
Novartis Pharmaceuticals UK are recalling a batch of Sandimmun Oral Solution due to the presence of crystals in the solution.
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Class 4 Medicines Defect Information: Rosemont Pharmaceuticals Ltd, Atorvastatin 4mg/ml Oral Suspension & Sildenafil 10mg/ml Oral Suspension , EL (22)A/39
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 O…
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Field Safety Notices: 5 to 9 September 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 September 2022
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Class 4 Medicines Defect Information: Quadrant Pharmaceuticals Limited, Bezalip Mono 400mg Tablets, EL (22)A/38
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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Field Safety Notices: 29 August to 2 September 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 29 August to 2 September 2022.
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Field Safety Notices: 22 to 26 August 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 22 to 26 August 2022
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Class 2 Medicines Recall: Hikma Pharmaceuticals USA Inc, Lorazepam 2mg/ml Injection, Lorazepam 4mg/ml Injection (unlicensed medicines), EL(22)A/37
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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Field Safety Notices: 15 to 19 August 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 August 2022.
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Class 2 Medicines Recall: Dysport 500 Units Powder for Solution for Injection, EL(22)A/36
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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Class 4 Medicines Defect Information, Rosuvastatin 5 mg, 10 mg and 20 mg film-coated tablets EL (22)A/35
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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Field Safety Notices: 8 to 12 August 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 August 2022.
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Field Safety Notices: 11 to 15 October 2021
List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 October 2021
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Class 2 Medicines Recall: Sun Pharmaceutical Industries Europe BV, Zoledronic acid SUN 5mg solution for infusion, EL(22)A/34
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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Field Safety Notices: 1 to 5 August 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 1 to 5 August 2022.
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Field Safety Notices: 11 to 15 July 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 July 2022.
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Company led medicines recall: Stockport Pharmaceuticals, Sodium Chloride Eye Drops 5% 1x10ml (unlicensed medicine), CLMR (22)A/06
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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National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Mexiletine hydrochloride 50mg, 100mg and 200 mg Hard Capsules, Clinigen Healthcare Ltd, due to a potential for underdosing and/or overdosing, NatPSA/2022/007/MHRA
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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Field Safety Notices: 25 to 29 July 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 July 2022.
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National Patient Safety Alert: Philips Health Systems V60, V60 Plus and V680 ventilators: potential unexpected shutdown leading to complete loss of ventilation (NatPSA/2022/002/MHRA)
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 …
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Field Safety Notices: 18 to 22 July 2022
List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 July 2022.
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Class 4 Medicines Defect Information: Novo Nordisk Limited, NovoRapid® FlexTouch® 100 units/ml, Saxenda® FlexTouch® (liraglutide) 6mg/ml, EL(22)A/33
Novo Nordisk Limited would like to notify you of a defect that affects specific batches of NovoRapid FlexTouch prefilled pen device and batches of Saxenda FlexTouch prefilled pen device in the UK.