Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.07.2020 – 31.08.2020

Великобританія

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

• Field Safety Notices: 17 – 21August 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 17 August to 21 August 2020.

• Alert type: Field safety notice

 Issued: 24 August 2020

• Class 2 Medicines Recall: Sanofi Fasturtec 7.5 mg, 1.5 mg/ml powder and solvent for concentrate for solution for infusion, EL (20)A/40

Sanofi is recalling batch number A9306 of the above product as a precautionary measure due to an out of specification result detected for Rasburicase enzyme activity according to a specific method and specifications for US m…

• Alert type: Drug alert

 Medical specialism: Pharmacy

 Issued: 24 August 2020

• Field Safety Notices: 10 – 14 August 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 10 August to 14 August 2020.

• Alert type: Field safety notice

 Issued: 17 August 2020

• Class 4 Medicines Defect Information: SmofKabiven extra Nitrogen Electrolyte Free, EL (20)A/39, PL 08828/0269

Fresenius Kabi Ltd & Calea UK Ltd has informed us of an error on the bag labels for SmofKabiven extra nitrogen electrolyte free, emulsion for infusion PL 08828/0269.

• Alert type: Drug alert

 Medical specialism: Pharmacy

 Issued: 13 August 2020

• Field Safety Notices – 31 July – 07 August 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 31 July to 07 August 2020.

• Alert type: Field safety notice

 

• Issued: 10 August 2020

• Class 2 Medicines Recall: Huddersfield Pharmacy Specials MS 19055, Phosphates Solution for Infusion 500ml, EL (20)A/38

Huddersfield Pharmacy Specials (HPS) is recalling the above batches of phosphates solution for infusion due to observation of precipitation in batch 500609X.

• Alert type: Drug alert

 Medical specialism: Pharmacy

 Issued: 10 August 2020

• Class 2 Medicines Recall: Pharmaram Ltd, Clexane 4,000 IU (40mg)/0.4ml Syringes, EL (20)A/37

Pharmaram Ltd has informed us that a specific batch of Clexane 4,000IU (40mg)/0.4ml syringes has an error on the labelling affixed to the plastic blister packaging encasing the syringe.

• Alert type: Drug alert

 Medical specialism: Pharmacy

 

• Issued: 4 August 2020

• Field Safety Notices – 27 July – 31 July 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 27 July to 31 July 2020

• Alert type: Field safety notice

 Issued: 3 August 2020

• Class 4 Medicines Defect Information: Crescent Pharma Ltd, SyreniRing 0.120 mg/0.015 mg per 24 hours, vaginal delivery system, EL (20)A/36

Crescent Pharma Ltd has informed us that the Patient Information Leaflet (PIL) within the packs for the below batches are missing important safety relevant text changes.

• Alert type: Drug alert

 Medical specialism: Pharmacy

 Issued: 3 August 2020

• Class 3 Medicines Recall: Accord-UK Ltd, Digoxin Tablets BP 250 micrograms, EL (20)A/35

Accord-UK Ltd has informed us of an issue related to decommissioning of a specific batch

• Alert type: Drug alert

 

• Medical specialism: Pharmacy

 

• Issued: 3 August 2020

• Class 2 Medicines Recall: Kyowa Kirin Limited, Abstral 200 microgram sublingual tablets, EL (20)A/34

Kyowa Kirin Limited is recalling a specific batch as a precautionary measure, due to the reports of double tablets in a single blister pocket.

• Alert type: Drug alert

 Medical specialism: Pharmacy

 Issued: 29 July 2020

• Field Safety Notices – 20 July – 24 July 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 20 July to 24 July 2020

• Alert type: Field safety notice

 Issued: 27 July 2020

• Class 3 Medicines Recall: Accord Healthcare Limited, Irinotecan Hydrochloride Concentrate for Solution for Infusion 20mg/ml (5ml vial), EL (20)A/33

Accord Healthcare Limited is recalling the above batch as a precautionary measure, due to the observation of precipitation in the solution in the same batch marketed in another country (Malta).

• Alert type: Drug alert

 Medical specialism: Pharmacy

 ssued: 23 July 2020

• Philips sterilizable defibrillator internal paddles (specific models) – may fail to deliver therapy if pre-use checks are not followed (MDA/2020/022)

Manufactured by Philips – defibrillator internal paddles may wear over time and might fail to deliver therapy, so it is important to do routine operational checks between each usage.

• Alert type: Medical device alert

 Medical specialism: Cardiology and 2 others

 Issued: 23 July 2020

• Class 4 Medicines Defect Information: Pfizer Limited, Ecalta 100mg powder for concentrate for solution for infusion, EL (20)A/32

Pfizer Limited has informed us that the packs for the affected batches below have not been packaged with the current version of the Patient Information Leaflet (PIL) containing updated storage instructions of the infusion so…

• Alert type: Drug alert

 Medical specialism: Pharmacy

 Issued: 23 July 2020

• Field Safety Notices – 13 July to 17 July 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 13 July to 17 July 2020

• Alert type: Field safety notice

 Issued: 20 July 2020