Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.09.2020 – 31.10.2020

Великобританія

https://www.gov.uk/drug-device-alerts?keywords=&alert_type[]=devices&issued_date[from]=&issued_date[to]=

• Medical Devices Safety Bulletin (MDSB/2020/02)

Regular safety information for healthcare professionals

• Alert type: Device safety information

 Issued: 5 November 2020

• Field Safety Notice: 26 to 30 October

List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 October 2020.

• Alert type: Field safety notice

 Issued: 2 November 2020

• Class 3 Medicines Recall: Theramex Ireland Ltd T/A Theramex HQ UK Ltd, AlfaD 0.25 microgram capsules (PL 49876/0001), EL (20) A/50

Theramex Ireland Ltd T/A Theramex HQ UK Ltd has informed us of an issue related to error in the decommissioning of a further batch.

• Alert type: Drug alert

 Medical specialism: Pharmacy

 Issued: 29 October 2020

• Field Safety Notice: 19 to 23 October

List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 October 2020.

• Alert type: Field safety notice

 Issued: 26 October 2020

• Company led drug alert – Optiray® 300mg I/ml Solution for Injection or Infusion (PL 12308/0028) and Optiray® 350mg I/ml Solution for Injection or Infusion (PL 12308/0032)

Guerbet Laboratories Limited is recalling certain batches of products as a precautionary measure due to reports received from healthcare professionals on the difficulties in attaching the Luer lock adapter to the Luer tip of…

• Alert type: Drug alert: company-led

 Medical specialism: Anaesthetics and 21 others

 Issued: 22 October 2020

• Field Safety Notice: 12 to 16 October

List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 October 2020.

• Alert type: Field safety notice

 Issued: 19 October 2020

• Medical Devices Safety Bulletin (MDSB/2020/01)

This is a new regular bulletin from Medicines and Healthcare products Regulatory Agency (MHRA) to inform health and care professionals of new or ongoing safety issues with medical devices.

• Alert type: Device safety information

 Issued: 19 October 2020

• Class 3 Medicines Recall: Metoprolol 50 mg Tablets (PL 20075/0304), EL (20)A/49

Accord Healthcare Ltd has informed us that when decommissioning at the pharmacy and scanning the serialised 2D code, the status of certain packs may report as ‘EXPORT.’

• Alert type: Drug alert

 Medical specialism: Pharmacy

 Issued: 14 October 2020

• Class 2 Medicines Recall: Sanofi Epilim 500mg Gastro-Resistant Tablets EL (20)A/48*

Sanofi is recalling batches of product as a precautionary measure due to out of specification results for disintegration test during routine stability testing.

• Alert type: Drug alert

 Medical specialism: Pharmacy

 Issued: 14 October 2020

• Field Safety Notices: 5 to 9 October 2020

List of field safety notices (FSNs) from medical device manufacturers from 5 October to 9 October 2020

• Alert type: Field safety notice

 Issued: 12 October 2020

• Class 2 Medicines Recall: Boots Dermacare 1% w/w Hydrocortisone Ointment (Batch 1DD), EL (20)A/47

The Boots Company PLC is recalling a specific batch of Hydrocortisone 1% w/w Ointment as a precautionary measure due to retained samples showing presence of Pseudomonas aeruginosa.

• Alert type: Drug alert

 Medical specialism: Pharmacy

 Issued: 6 October 2020

• Field Safety Notices: 28 September to 02 October 2020

List of field safety notices (FSNs) from medical device manufacturers from 28 September to 02 October 2020

• Alert type: Field safety notice

 Issued: 5 October 2020

• Class 3 Medicines Recall: Theramex Ireland Ltd T/A Theramex HQ UK Ltd, AlfaD Capsules, EL (20) A/46

Theramex Ireland Ltd T/A Theramex HQ UK Ltd has informed us that when decommissioning at the pharmacy and when scanning the serialised 2D code, the status of certain packs of AlfaD capsules may report as ‘EXPORT’

• Alert type: Drug alert

 Issued: 29 September 2020

• Field Safety Notice: 21 to 26 September 2020

List of field safety notices (FSNs) from medical device manufacturers from 21 to 26 September 2020

• Alert type: Field safety notice

 Issued: 28 September 2020

• Field Safety Notice: 12 to 16 August 2019

List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 August 2019.

• Alert type: Field safety notice

 Issued: 19 August 2019

• National Patient Safety Alert: Philips Respironics V60 ventilator – unexpected shutdown (NatPSA/2020/007/MHRA)

Actions to be taken to avoid potential unexpected shutdown leading to complete loss of ventilation

• Alert type: National patient safety alert

 Medical specialism: Critical care

 ssued: 23 September 2020

• Field Safety Notices: 14 to 18 September 2020

List of Field Safety Notices (FSNs) from medical device manufacturers from 14 September to 18 September 2020

• Alert type: Field safety notice

 Issued: 21 September 2020

• Class 2 FMD Medicines Recall, Parallel Distributed Medicines, Multiple Products, EL (20)A/45

Medicines from the listed parallel distributors are being recalled due to concerns that the supply chain may have been compromised and the origins of the products are unknown

• Alert type: Drug alert

 Medical specialism: Pharmacy

 Issued: 16 September 2020

• Field Safety Notices: 7 to 11 September 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 7 to 11 September 2020.

• Alert type: Field safety notice

 Issued: 14 September 2020

• Class 4 Medicines Defect Information: Zopiclone Tablets, Ratiopharm UK Limited and Generics [UK] Limited t/a Mylan, EL (20)A/44

Ratiopharm UK Limited and Generics [UK] Limited t/a Mylan have confirmed that the Patient Information Leaflet (PIL) within all packs and the Summary of Product Characteristics (SmPC) for Ratiopharm is missing important …

• Alert type: Drug alert

 Medical specialism: Pharmacy

 Issued: 10 September 2020

• Field Safety Notices: 1 to 4 September 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 1 to 4 September 2020.

• Alert type: Field safety notice

 Issued: 7 September 2020

• Class 3 Medicines Recall: Accord Healthcare Limited, Amlodipine 10mg Tablets

Accord Healthcare Limited is recalling a specific batch of Amlodipine 10mg Tablets as a precautionary measure due to out of specification results obtained during stability testing.

• Alert type: Drug alert

 Medical specialism: Pharmacy

 Issued: 7 September 2020

• Class 4 FMD Medicines Information: WDA(H) 49276 Kingsley Specials Ltd, Multiple Products, (EL (20)A/42)

The MHRA is currently investigating an incident where several medicines appear to have left the legal supply chain and have then been re-introduced via Kingsley Specials Ltd WDA(H) 49276, who purchased from a company that do…

• Alert type: Drug alert

 Issued: 1 September 2020

• 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.

• Alert type: Field safety notice

 Issued: 1 September 2020

• Class 2 Medicines Recall: GL Pharma GmbH, Oxylan 40mg prolonged-release tablets, EL (20)A/41

GL Pharma is recalling a specific batch of Oxylan 40mg prolonged-release tablets due to out of specification results for dissolution during routine stability testing.

• Alert type: Drug alert

 edical specialism: Pharmacy  Issued: 1 September 2020