Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.10.2022 – 30.12.2022

Великобританія

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: 26 to 30 December 2022

List of Field Safety Notices (FSNs) from 26 to 30 December 2022.

Alert type: Field safety notice

Issued: 30 December 2022

Field Safety Notices: 19 to 23 December 2022

List of Field Safety Notices (FSNs) from 19 to 23 December 2022.

Alert type: Field safety notice

Issued: 23 December 2022

Class 4 Medicines Defect Information: Galderma (U.K.) Limited, Epiduo 0.1% / 2.5% gel (45 g), EL (22)A/52

Galderma (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in some batches of Epiduo 0.1% / 2.5% gel contain outdated safety information regarding pregnancy.

Medical specialism: Dispensing GP practices and 2 others

Issued: 19 December 2022

Class 4 Medicines Defect Information: Galderma (U.K.) Limited, Etrivex 500 micrograms/g Shampoo, EL (22)A/51

Galderma (U.K.) Limited has informed the MHRA that the patient information leaflet (PIL) packaged in specific batches of Etrivex Shampoo is missing safety information

Medical specialism: Dispensing GP practices and 2 others

Issued: 6 December 2022

Field Safety Notices: 28 November to 2 December 2022

List of Field Safety Notices (FSNs) from 28 November to 2 December 2022

Alert type: Field safety notice

Issued: 5 December 2022

Class 4 Medicines Defect Information: ADVANZ PHARMA, MacroBID 100mg Prolonged-Release Capsules, EL (22)A/50

ADVANZ PHARMA has made the MHRA aware that certain batches of MacroBID 100mg Prolonged-Release Capsules have been packed with the incorrect Patient Information Leaflet (PIL).

Medical specialism: Dispensing GP practices and 2 others

Issued: 5 December 2022

Class 4 Medicines Defect Information: Lucis Pharma Ltd, Oxycodone Hydrochloride 10mg/ml oral solution, EL (22)A/49

Lucis Pharma Ltd has informed the MHRA that there is a typographical error with text on the rear side of the outer packaging for Oxycodone Hydrochloride 10mg/ml Oral Solution.

Medical specialism: Dispensing GP practices and 2 others

Issued: 29 November 2022

Field Safety Notices: 21 to 25 November 2022

List of Field Safety Notices (FSNs) from 21 to 25 November 2022

Alert type: Field safety notice

Medical specialism: Anaesthetics and 22 others

Issued: 28 November 2022

Field Safety Notices: 14 to 18 November 2022

List of Field Safety Notices (FSNs) from 14 to 18 November 2022

Alert type: Field safety notice

Issued: 21 November 2022

Class 4 Medicines Defect Information: Morningside Healthcare Limited, Hyoscine Butylbromide 20 mg Film-coated Tablets, EL (22)A/48

Morningside Healthcare Limited has informed the MHRA of an error with the Patient Information Leaflet (PIL) packaged in batch 22237001 of Hyoscine Butylbromide 20 mg Film-coated Tablets.

Medical specialism: Dispensing GP practices and 2 others

Issued: 21 November 2022

Class 4 Medicines Defect Information: Macarthys Laboratories t/a Martindale Pharma, Venlafaxine XL 300 mg prolonged-release tablets, EL(22)A/47

Martindale Pharma has made the MHRA aware that the GTIN in the 2D barcode and the printed variable data represents the branded version of the product (Venlalic® XL 300 mg prolonged-release tablets).

Medical specialism: Dispensing GP practices and 2 others

Issued: 16 November 2022

Field Safety Notices: 7 to 11 November 2022

List of Field Safety Notices (FSNs) from 7 to 11 November 2022

Alert type: Field safety notice

Issued: 14 November 2022

National Patient Safety Alert: Class 4 Medicines Defect Information: Prenoxad 1mg/ml Solution for Injection, Macarthys Laboratories (Aurum Pharmaceuticals Ltd/Ethypharm Group), due to potential missing needles in sealed kits, NatPSA/2022/009/MHRA

Macarthys Laboratories (trading as Martindale Pharma, an Ethypharm Group Company), has notified the MHRA of a limited number of Prenoxad packs in a batch marketed in France with missing needles.

Medical specialism: Anaesthetics and 22 others

Issued: 10 November 2022

Field Safety Notices: 31 October to 4 November 2022

List of Field Safety Notices (FSNs) from 31 October to 4 November 2022

Alert type: Field safety notice

Issued: 8 November 2022

Field Safety Notices: 24 to 28 October 2022

List of Field Safety Notices (FSNs) from 24 to 28 October 2022

Alert type: Field safety notice

Issued: 31 October 2022

Class 3 Medicines Recall: Medreich PLC, Mebeverine hydrochloride 135mg Film-coated tablets, EL (22)A/46

Medreich PLC UK is recalling a batch of Mebeverine hydrochloride 135mg film-coated tablets as a precautionary measure due to out of specification results for tablet dissolution during routine product release testing.

Medical specialism: Dispensing GP practices and 1 others

Issued: 27 October 2022

Class 4 Medicines Defect Information: Recordati Rare Diseases, Pedea 5 mg/ml solution for injection, EL(22)A/45

Recordati Rare Diseases T/A Recordati Rare Diseases UK Ltd has made the MHRA aware that specific batches of Pedea 5 mg/ml solution for injection have been packaged with the incorrect Product Information Leaflet (PI…

Medical specialism: Cardiology and 5 others

Issued: 25 October 2022

Field Safety Notices: 17 to 21 October 2022

List of Field Safety Notices (FSNs) from 17 to 21 October 2022

Alert type: Field safety notice

Issued: 24 October 2022

National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Targocid 200mg powder for solution for injection/infusion or oral solution, Aventis Pharma Limited t/a Sanofi, due to the presence of bacterial endotoxins, NatPSA/2022/008/MHRA

Sanofi UK is initiating an urgent recall of two batches of Targocid 200mg powder for solution for injection/infusion or oral solution

Alert type: National patient safety alert

Medical specialism: Anaesthetics and 22 others

Issued: 21 October 2022

Class 2 Medicines Recall: hameln pharma ltd, Ephedrine Hydrochloride 30 mg/ml Solution for Injection, EL(22)A/44

hameln pharma ltd is initiating a recall of the affected batches of Ephedrine Hydrochloride 30 mg/ml Solution for Injection as a precautionary measure.

Medical specialism: Anaesthetics and 5 others

Issued: 20 October 2022

Field Safety Notices: 10 to 14 October 2022

List of Field Safety Notices (FSNs) from 10 to 14 October 2022

Alert type: Field safety notice

Issued: 17 October 2022

Field Safety Notice: 23 to 27 December 2019

List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 December 2019.

Alert type: Field safety notice

Issued: 30 December 2019

Class 4 Medicines Defect Information: Flamingo Pharma UK Ltd, Ibuprofen 400mg Tablets, Paracetamol 500mg Tablets (Caplets), EL (22)A/43

Flamingo Pharma UK Ltd has identified an error relating to the ink printing of the batch number and expiry date on the carton for three batches of Ibuprofen 400mg Tablets. This notification includes all potentially impacted …

Medical specialism: Dispensing GP practices and 2 others

Issued: 12 October 2022

Field Safety Notices: 04 to 08 October 2021

List of field safety notices (FSNs) from medical device manufacturers from 04 to 08 October 2021

Alert type: Field safety notice

Issued: 11 October 2021

Class 2 Medicines Recall: hameln pharma ltd, Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion, EL (22)A/42

hameln pharma ltd is initiating a recall of batch 210505 of Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion as a precautionary measure

Medical specialism: Anaesthetics and 6 others

Issued: 11 October 2022

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

Field safety notice (FSN) 03 to 07 October

List of field safety notices for week 03 to 07 October 2022

Alert type: Field safety notice

Issued: 10 October 2022

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.

Medical specialism: Dispensing GP practices and 2 others

Issued: 6 October 2022