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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.
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Class 4 Medicines Defect Information: Omega Pharma Limited, Niquitin 14mg Clear Patch (14 patches), EL(22)A/32
Omega Pharma Limited have identified an error relating to the product packaging.
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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/31
hameln pharma ltd is initiating a recall of batch 207506 of Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion as a precautionary measure.
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Class 4 Medicines Defect Information: Thornton & Ross, Covonia Night Time Formula and Covonia Original Bronchial Balsam, EL(22)A/30
Thornton & Ross have identified that the product labelling for some batches of ‘Pharmacy’ medicines do not contain the ‘P’ symbol, due to a packaging error on the bottle.
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Field Safety Notices: 4 to 8 July 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 4 to 8 July 2022.
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Field Safety Notices: 27 June to 1 July 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 27 June to 1 July 2022
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Field Safety Notices: 20 to 24 June 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 20 to 24 June 2022
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Company led medicines recall: A.Vogel Ltd, Linoforce granules 12 years plus (THR 13668/0021), CLMR (22)A/05
A.Vogel Ltd is recalling a specific batch of Pharmacy only medicine due to a small number of packs that were inadvertently supplied to non-pharmacy retail outlets.
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Field Safety Notices: 13 to 17 June 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 June 2022
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Class 4 Medicines Defect Information: Altan Pharma Limited, Phenylephrine 0.08 mg/ml - solution for injection/infusion, EL(22)A/29
Altan Pharma Limited have identified an error relating to the product packaging. The incorrect concentration of phenylephrine base is provided on the overwrapping bag label.
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Company led medicines recall: PCCA Limited, Ketamine 50mg in 5ml Oral Solution and Ketamine 100mg in 5ml Oral Solution (unlicensed medicines), CLMR (22)A/04
PCCA Limited have been made aware of an issue with the appearance of Ketamine 50mg in 5ml Oral Solution and Ketamine 100mg in 5ml Oral Solution.
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Field Safety Notices: 6 to 10 June 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 6 to 10 June 2022
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Class 2 Medicines Recall: Bristol Laboratories Limited, Phenobarbital 60 mg Tablets, EL(22)A/28
Bristol Laboratories Limited are recalling a batch of this product as a precautionary measure due to low dissolution test results reported during ongoing stability studies.
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Field Safety Notices: 30 May to 3 June 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 30 May to 3 June 2022.
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Class 4 Medicines Defect Information: OxyContin 20 mg prolonged release tablets, EL (22)A/27
Napp Pharmaceuticals Limited have identified an error relating to the Braille printed on the cartons. The
Braille message on the Oxycontin 20mg prolonged release tablets incorrectly states strength as 15mg.
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Class 4 Medicines Defect Information: Esomeprazole 40mg Powder for Solution for Injection/Infusion, EL (22)A/26
DEMO SA PHARMACEUTICAL INDUSTRY has informed us that the Product Code/GTIN (PC) number found on the above batch is incorrect. The GTIN number that should have been allocated for this batch is 5200040321010.
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Field Safety Notices: 23 to 27 May 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 May 2022.
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Company led medicines recall: Consilient Health UK Ltd, Invita D3 800 IU Soft Capsules, CLMR (22)A/03
Consilient Health UK Ltd is recalling a specific batch due to limited units from the batch being distributed prior to batch release.
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Class 4 Medicines Defect Information: Orifarm UK Ltd, Loprazolam 1mg Tablets, EL (22)A/25
Orifarm UK have informed us of an error with the Patient Information Leaflet (PIL) packaged within the packs of certain batches. The product name stated in the heading of the PIL has been spelt incorrectly as “lorazolam”, in…
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National Patient Safety Alert: NovoRapid PumpCart in the Roche Accu-Chek Insight insulin pump: risk of insulin leakage causing hyperglycaemia and diabetic ketoacidosis (NatPSA/2022/004/MHRA)
The MHRA continues to receive serious reports of harm associated with insulin leakage for the NovoRapid PumpCart prefilled insulin cartridge in the Accu-Chek Insight Insulin pump. In some patients, there were serious consequ…
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Class 2 Medicines Recall: hameln pharma ltd, Water for Injections BP – 100ml vial, EL (22)A/24
hameln pharma ltd are recalling batches of product additional to the batch recalled on 15 February 2022 (reference EL(22)A/06).
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Field Safety Notices: 16 to 20 May 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 May 2022.
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Class 4 Medicines Defect Information: GlaxoSmithKline UK Ltd, Zovirax I.V. 500 mg, EL (22)A/22
GlaxoSmithKline UK Ltd have informed the MHRA that an incorrect version of the Summary of Product Characteristics section 4.2 and the Patient Information Leaflet is inside the sealed pack, and contains unapproved text.
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Class 2 Medicines Recall: Quadrant Pharmaceuticals Ltd, Mefenamic Acid 500mg film coated tablets, EL (22)A/23
Quadrant Pharmaceuticals Ltd are recalling a specific batch of Mefenamic Acid 500mg Film-Coated Tablets as a precautionary measure, due to observations of a defective layer of film coating in some tablets, resulting in the t…
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Field Safety Notices: 09 to 13 May 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 09 to 13 May 2022