Головна / Моніторинг Великобританія / Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2022 – 31.03.2022

Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2022 – 31.03.2022

Опубліковано 18.04.2022 о 10:58

Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2022 – 31.03.2022

 

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

 

The MHRA’s recommendations for using paclitaxel-coated devices in patients with intermittent claudication and critical limb ischaemia.

List of field safety notices (FSNs) from medical device manufacturers from 28 March to 1 April 2022.

List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 March 2022.

Pfizer Ltd are recalling batch number DD4842 as a precautionary measure due to the identification of a nitrosamine above the acceptable limit.

List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 March 2022.

Brancaster Pharma Limited have notified us of an issue relating to the label of the Water for Injections (solvent) packaged in each finished product pack.

Advanced Accelerator Applications is recalling specific batches of this product as a precautionary measure due to an out of specification result that was identified during stability testing.

List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 March 2022.

Ayrton Saunders Limited have identified an error relating to the Braille printed on the cartons.

CNX Therapeutics Ltd. have notified the MHRA that the batches of Latuda film-coated tablets listed in this notification will be released without EAN barcodes on the cartons.

Boots have identified an error with the printed patient information leaflet provided with batches of the Decongestant Tablets and Decongestant with Pain Relief Tablets.

List of field safety notices (FSNs) from medical device manufacturers from 28 February to 4 March 2022.

Wockhardt UK Ltd are recalling a batch of Diazepam RecTubes 2.5mg Rectal Solution due to an out of specification result for assay during routine stability testing.

    • Medical specialism: Dispensing GP practices and 1 others
    • Issued: 7 March 2022

  Field Safety Notices: 21 to 25 February 2022

List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 February 2022.

  • Alert type: Field safety notice
  • Issued: 2 March 2022

  Class 3 Medicines Recall: Kyowa Kirin Services Ltd. Isotard 60mg XL Tablets, EL (22)A/10

Kyowa Kirin Services Ltd. are recalling a batch of Isotard 60mg XL Tablets as a precautionary measure due to microfibres/crystals of the Active Pharmaceutical Ingredient (API) being present on the surface of the tablets…

  • Medical specialism: Dispensing GP practices and 1 others
  • Issued: 2 March 2022

  UPDATE: Class 4 Medicines Defect Information: Atnahs Pharma UK Limited, Naprosyn Tablets (all strengths), Naprosyn EC 250mg Gastro-Resistant Tablets, Naprosyn EC 500mg Gastro-Resistant Tablets, EL (22)A/09

Atnahs Pharma UK Limited have identified additional missing information on the PIL of the certain product batches.

  • Medical specialism: Dispensing GP practices and 1 others
  • Issued: 23 February 2022

  Field Safety Notices: 14 to 18 February 2022

List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 February 2022.

  • Alert type: Field safety notice
  • Issued: 21 February 2022

  Class 2 Medicines Recall: medac GmbH (t/a medac Pharma LLP), Fluorouracil Injection, 50 mg/ml, solution for injection (2500mg/50ml vial), EL (22)A 08

medac GmbH (t/a medac Pharma LLP) are recalling certain product batches as a precautionary measure due to visual detection of glass lamellae particles during an ongoing stability study.

  • Medical specialism: Dispensing GP practices and 1 others
  • Issued: 17 February 2022

  Surdial X Haemodialysis machine: potential for devices to remove excess fluid outside of machine specification. DSI/2022/002

The MHRA are aware of instances of Surdial X machines removing excess fluid via ultrafiltration outside of its specification. There is a risk to patients who are unable to tolerate excess fluid removal.

  • Alert type: Device safety information
  • Medical specialism: Renal medicine
  • Issued: 17 February 2022

  Stop using Vaginal Speculums with smoke tube and Gynaecological Hysteroscopy sheaths from Gemini Surgical UK: all lots and batches. DSI/2022/001

The MHRA has become aware that Vaginal Speculums with smoke tube and Gynaecological Hysteroscopy sheaths from Gemini Surgical UK are being sold with a falsely applied CE mark. This means that these devices have been sold wit…

  • Alert type: Device safety information
  • Medical specialism: General surgery and 1 others
  • Issued: 17 February 2022

  Class 2 Medicines Recall: Uni Health Distribution, Efudix 5% w/w cream, EL (22)A 07

Uni Health Distribution is aware of a potential issue where the leaflet contained within Efudix 5% w/w cream (2 x 20g) pack, batch 80193439/B may be incorrect.

  • Medical specialism: Pharmacy
  • Issued: 17 February 2022

  Field Safety Notices: 7 to 11 February 2022

List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 February 2022.

  • Alert type: Field safety notice
  • Issued: 15 February 2022

  Class 2 Medicines Recall: hameln pharma ltd, Water for Injections BP – 100ml vial, EL (22)A 06

hameln pharma ltd is recalling a batch of a product as a precautionary measure as remaining vials may no longer be in line with the licensed product specification

  • Medical specialism: Pharmacy
  • Issued: 15 February 2022

  Company led medicines recall: Bucain Hyperbar 5mg/ml Solution for Injection (unlicensed medicine), CLMR (22)A/01

Mawdsley-Brooks & Company Limited (UK importer) is recalling a specific batch of this product as a precautionary measure due out of specification result for pH that was identified during routine stability testing.

  • Medical specialism: Pharmacy
  • Issued: 14 February 2022

  Field Safety Notices: 31 January to 4 February 2022

List of field safety notices (FSNs) from medical device manufacturers from 31 January to 4 February 2022.

  • Alert type: Field safety notice
  • Issued: 8 February 2022

  Class 4 Medicines Defect Information: Atnahs Pharma UK Limited, Naprosyn Tablets (all strengths), Naprosyn EC 250mg Gastro-Resistant Tablets, EL (22)A/05

Atnahs Pharma UK Limited have identified missing information on the PIL of the above batches.

  • Medical specialism: Dispensing GP practices and 1 others
  • Issued: 3 February 2022

  Class 4 Medicines Defect Information: Flamingo Pharma UK Ltd, Ibuprofen 400mg Tablets, EL (22)A/04

Flamingo Pharma UK Ltd have identified an error relating to the embossed batch number on some cartons of Ibuprofen 400mg tablets.

  • Medical specialism: Pharmacy
  • Issued: 1 February 2022

  Field Safety Notices: 24 to 28 January 2022

List of field safety notices (FSNs) from medical device manufacturers from 24 to 28 January 2022.

  • Alert type: Field safety notice
  • Issued: 31 January 2022

  Class 4 Medicines Defect Information: Antibiotice SA, Piperacillin / Tazobactam 4g/0.5 g, powder for solution for infusion, EL (22)A/03

Antibiotice SA have identified an error on PIL of the above batches regarding the sodium content.

  • Medical specialism: Pharmacy
  • Issued: 31 January 2022

  Class 4 Medicines Defect Information: Fresenius Kabi Limited, Kabiven Emulsion for Infusion, EL (22)A/02

Fresenius Kabi Limited have identified an error on the infusion bag packaged in certain batches.

  • Medical specialism: Pharmacy
  • Issued: 25 January 2022

  Field Safety Notices: 17 to 21 January 2022

List of field safety notices (FSNs) from medical device manufacturers from 17 to 21 January 2022.

  • Alert type: Field safety notice
  • Issued: 25 January 2022

  Class 2 Medicines Recall: SANTEN Oy (trading as Santen UK Limited) IKERVIS 1 mg/mL eye drops, emulsion , EL (22)A/01

SANTEN Oy (trading as Santen UK Limited) are recalling the above 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: 19 January 2022

  Field Safety Notices: 10 to 14 January 2022

List of field safety notices (FSNs) from medical device manufacturers from 10 to 14 January 2022.

  • Alert type: Field safety notice
  • Issued: 17 January 2022

  Field Safety Notices: 3 to 7 January 2022

List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 January 2022

  • Alert type: Field safety notice
  • Issued: 10 January 2022

 

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