Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.07.2022 – 30.09.2022 Великобританія

Опубліковано 18.10.2022 о 15:31

Великобританія

https://www.gov.uk/drugdevicealerts?keywords=&alert_type[]=devices&issued_date[from]=&issued_date[to]=

 

https://www.gov.uk/drug-device-alerts

https://www.gov.uk/drug-device-alerts?page=2

 

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.

Alert type: Field safety notice

Issued: 3 October 2022

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.

Alert type: Field safety notice

Issued: 26 September 2022

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…

Alert type: Device safety information

Medical specialism: Critical care and 1 others

Issued: 21 September 2022

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

Alert type: Field safety notice

Issued: 20 September 2022

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.

Medical specialism: Dispensing GP practices and 1 others

Issued: 20 September 2022

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…

Medical specialism: Dispensing GP practices and 1 others

Issued: 13 September 2022

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

Alert type: Field safety notice

Issued: 12 September 2022

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.

Medical specialism: Dispensing GP practices and 1 others

Issued: 12 September 2022

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.

Alert type: Field safety notice

Issued: 5 September 2022

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

Alert type: Field safety notice

Issued: 29 August 2022

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.

Medical specialism: Anaesthetics and 22 others

Issued: 30 August 2022

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.

Alert type: Field safety notice

Issued: 24 August 2022

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.

Medical specialism: Dispensing GP practices and 1 others

Issued: 22 August 2022

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.

Medical specialism: Dispensing GP practices and 1 others

Issued: 17 August 2022

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.

Alert type: Field safety notice

Issued: 15 August 2022

Field Safety Notices: 11 to 15 October 2021

List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 October 2021

Alert type: Field safety notice

Issued: 19 October 2021

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.

Medical specialism: Dispensing GP practices and 1 others

Issued: 11 August 2022

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.

Alert type: Field safety notice

Issued: 8 August 2022

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.

Alert type: Field safety notice

Issued: 18 July 2022

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).

Medical specialism: Dispensing GP practices and 1 others

Issued: 8 August 2022

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.

Alert type: National patient safety alert

Medical specialism: Anaesthetics and 22 others

Issued: 4 August 2022

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.

Alert type: Field safety notice

Issued: 1 August 2022

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 …

Alert type: National patient safety alert

Medical specialism: Anaesthetics and 2 others

Issued: 29 March 2022

Field Safety Notices: 18 to 22 July 2022

List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 July 2022.

Alert type: Field safety notice

Issued: 25 July 2022

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.

Issued: 21 July 2022

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.

Medical specialism: Pharmacy

Issued: 20 July 2022

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.

Medical specialism: Anaesthetics and 6 others

Issued: 19 July 2022

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.

Medical specialism: Pharmacy

Issued: 14 July 2022

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.

Alert type: Field safety notice

Issued: 11 July 2022

 

 

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