Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.07.2021 – 30.09.2021

https://www.gov.uk/drug-device-alerts?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: 27 September to 01 October 2021

List of field safety notices (FSNs) from medical device manufacturers from 27 September to 01 October 2021

• Alert type: Field safety notice

 Issued: 4 October 2021

• Company led medicines recall: Glucose 10%w/v 10ml injection (unlicensed medicine) and Trometamol 7%w/v injection 5mL (unlicensed medicine)

East Suffolk and North Essex NHS Foundation Trust (MS 12882) is recalling specific batches of Glucose 10%w/v injection 10mL and Trometamol 7%w/v injection 5mL due to limited assurance of product sterility.

• Medical specialism: Pharmacy

 Issued: 4 October 2021

• Field Safety Notices: 20 to 24 September 2021

List of field safety notices (FSNs) from medical device manufacturers from 20 to 24 September 2021

• Alert type: Field safety notice

 Issued: 27 September 2021

• Class 2 Medicines Recall: Accord-UK Ltd (Trading style: NorthStar), LEVOTHYROXINE TABLETS BP 50 micrograms EL (21)A/23

Accord-UK Ltd (Trading style: NorthStar) are recalling the above batch of product as a precautionary measure due to tablet hardness failures, leading to crumbling and breaking tablets.

• Medical specialism: Dispensing GP practices and 1 others

 

• Issued: 27 September 2021

• Field Safety Notices: 13 to 17 September 2021

List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 September 2021

• Alert type: Field safety notice

 Issued: 20 September 2021

• Class 2 Medicines Recall: SANTEN Oy (trading as Santen UK Limited), IKERVIS 1 mg/mL eye drops, emulsion, EL (21)A/22

SANTEN Oy (trading as Santen UK Limited) are recalling two batches of products as a precautionary measure due to detection of particles/crystals of the active pharmaceutical ingredient ciclosporin.

• Medical specialism: Dispensing GP practices and 1 others

 

• Issued: 15 September 2021

• Field Safety Notices: 6 to 10 September 2021

List of field safety notices (FSNs) from medical device manufacturers from 6 to 10 September 2021

• Alert type: Field safety notice

 Issued: 13 September 2021

• Class 4 Medicines Defect Information, Rosuvastatin 5 mg, 10 mg, 20 mg and 40 mg film-coated tablets (EL (21)A/21)

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: 9 September 2021

• Field Safety Notices: 30 August to 3 September 2021

List of field safety notices (FSNs) from medical device manufacturers from 30 August to 3 September 2021.

• Alert type: Field safety notice

 Issued: 6 September 2021

• Medical device alerts archived in September 2021

Following our latest review of medical device alerts, we have archived the ones listed below.

• Alert type: Device safety information

 Issued: 2 September 2021

• Field Safety Notices: 23 to 27 August 2021

List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 August

• Alert type: Field safety notice

 Issued: 31 August 2021

• Class 2 Medicines Recall: Rosemont Pharmaceuticals Limited, Metformin Hydrochloride 500mg/5ml Oral Solution, PL 00427/0139, EL (21)A/20

Rosemont Pharmaceuticals Limited is recalling a specific batch of Metformin Hydrochloride 500mg/5ml Oral Solution due to identification of an impurity above the acceptable limit.

• Medical specialism: Anaesthetics and 21 others

 Issued: 25 August 2021

• Field Safety Notices: 16 to 20 August 2021

List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 August

• Alert type: Field safety notice

 Issued: 23 August 2021

• Field Safety Notices: 9 to 13 August 2021

List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 August

• Alert type: Field safety notice

 Issued: 16 August 2021

• Field Safety Notices: 2 to 6 August 2021

List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 August

• Alert type: Field safety notice

 Issued: 9 August 2021