Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.04.2021 – 30.06.2021

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

 

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

 

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.

 

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

 

Accord Healthcare have informed us of an error with the patient information leaflets (PILs) that have been packaged in some Rosuvastatin products.

 

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

 

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

 

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

 

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.

 

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

 

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

 

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

 

Specific batches of products supplied by the Marketing Authorisation Holders and parallel distributor companies are being recalled due to presence of a mutagenic impurity.

 

Summary list of field safety notices (FSNs) from medical device manufacturers from 26 to 30 July 2021

 

Summary list of field safety notices (FSNs) from medical device manufacturers from 19 to 23 July 2021.

 

Summary list of field safety notices (FSNs) from medical device manufacturers from 11 to 16 July 2021.

 

Brown & Burk UK Limited have noticed an error regarding specific batches of Amoxicillin 500 mg/ 5 ml Powder for oral suspension. The product information incorrectly states the quantity of the excipient sodium benzoa…

 

Summary list of field safety notices (FSNs) from medical device manufacturers from 5 to 9 July 2021.

 

Napp Pharmaceuticals Limited have noticed and an error in the PIL of specific batches of Sevredol 10 mg Tablets and Sevredol 20 mg Tablets.

 

Galderma UK identified an error regarding an older version of artwork being used and packed with specific batches of Tetralysal 300mg Hard Capsules.

 

Summary list of field safety notices (FSNs) from medical device manufacturers from 28 June to 2 July 2021.

 

Nova Laboratories Limited (MS 13581) is recalling specific batches of the impacted products due to a potential risk of contamination.

 

Kyowa Kirin Limited is recalling specific batches as a precautionary measure, due to the reports of glass and cellulose fibre contamination, which was identified during stability and reference sample inspection.

 

Fraudulent activity by this third-party sterilisation provider has been identified. Multiple medical device manufacturers are affected. Manufacturers are advising customers of actions required to mitigate risks.

 

Summary list of field safety notices (FSNs) from medical device manufacturers from 21 to 25 June 2021.

 

Philips have issued 2 FSNs about selected ventilators and CPAP and BiPAP devices.

 

 

Summary list of field safety notices (FSNs) from medical device manufacturers from 14 to 18 June 2021.

 

Specific batches of products supplied by Bristol Laboratories Limited, Brown & Burk UK Limited and Teva UK Limited are being recalled due to presence of a mutagenic impurity.

 

Zentiva Pharma UK Limited is recalling the above batch of Co-codamol 30/500 Effervescent Tablets as a precautionary measure due to an issue with the homogeneity of the batch. This issue means that there is the potential…

 

 

Summary list of field safety notices (FSNs) from medical device manufacturers from 7 to 11 June 2021.

 

The importer and distributor of the above products (Eaststone Limited) has informed us of reports that two affected batches may be contaminated with mould.

 

Summary list of field safety notices (FSNs) from medical device manufacturers from 31 May to 4 June 2021.

 

Summary list of field safety notices (FSNs) from medical device manufacturers from 24 to 28 May 2021.

 

Summary list of field safety notices (FSNs) from medical device manufacturers from 17 to 21 May 2021.

 

Advanz Pharma is recalling batches of carbimazole tablets due to an out of specification observation for tablet appearance of samples during routine stability testing.

 

Becton Dickinson (BD) is recalling all ethylene oxide (EtO) sterilised BD Venflon Pro Safety (VPS) and Venflon Pro IV Cannulae after identifying an increase in reports of leakage from the injection port.

 

 

Advanced Accelerator Applications (UK & Ireland) Ltd is recalling a specific batch as it was identified during the inspection process by the manufacturer that a small number of bags were observed to be leaking.

 

Summary list of field safety notices (FSNs) from medical device manufacturers from 10 to 14 May 2021

 

AstraZeneca UK Limited is recalling the above batch of Bricanyl 0.5mg/ml solution for injection or infusion as a precautionary measure due to out of specification results for a routinely tested known impurity during sta…

 

Recommendations for clinicians including not implanting these devices

 

 

Summary list of field safety notices (FSNs) from medical device manufacturers from 3 to 7 May 2021

 

Summary list of field safety notices (FSNs) from medical device manufacturers from 26 April to 30 April 2021

 

Lupin Healthcare (UK) Limited has informed us of a discrepancy with the product packaging for several batches of Syonell 250mg Gastro-Resistant Tablets and Syonell 500mg Gastro-Resistant Tablets. This discrepancy relates to …

 

Summary list of field safety notices (FSNs) from medical device manufacturers from 19 April to 23 April 2021

 

Ennogen Pharma Limited are recalling an affected batch of Trimethoprim 200mg Tablets as a precautionary measure due to the observation of a foreign tablet, which is identified as Trimethoprim 100mg Tablet.

 

Diffuplast has identified a potential issue with their third-party sterilisation provider. The risk to patients is very low and therefore patients should continue to use their products as normal.

 

Summary list of field safety notices (FSNs) from medical device manufacturers from 12 April to 16 April 2021

 

Summary list of field safety notices (FSNs) from medical device manufacturers from 05 April to 09 April 2021

 

Users of this continuous glucose monitoring system may experience adverse skin reactions to the sensor.

 

List of field safety notices (FSNs) from medical device manufacturers from 29 March to 02 April 2021.

 

List of field safety notices (FSNs) from medical device manufacturers from 22 March to 26 March 2021.