Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2021 – 31.03.2021

https://www.gov.uk/drug-device-alerts

https://www.gov.uk/drug-device-alerts?page=2

 

• Field Safety Notices – 22 to 26 March 2021

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

• Alert type: Field safety notice

 Issued: 29 March 2021

• Medoject sterile hypodermic and blunt fill needles manufactured by Chirana T. Injecta – discontinue use (DSI/2021/003)

There is the potential for a black residue to be present on all Medoject hypodermic and blunt fill needles

• • Alert type: Device safety information

 Issued: 29 March 2021

• Field Safety Notices: 15 to 19 March 2021

List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 March 2021.

• • Alert type: Field safety notice

 Issued: 22 March 2021

• Class 4 Medicines Defect Information, Caffeine Citrate 10mg/ml Solution for Injection, (PL 01883/0344), EL (21)A/09

Macarthys Laboratories Limited T/A Martindale Pharma has informed us that the EAN barcode on the outer carton of a specific batch of Caffeine Citrate 10mg/ml Solution for Injection is incorrect.

• • Medical specialism: Pharmacy

 Issued: 18 March 2021

• Field Safety Notices: 8 to 12 March 2021

List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 March 2021

• • Alert type: Field safety notice

 Issued: 15 March 2021

• Class 3 Medicines Recall: Thame Laboratories, Itraconazole 10mg/ml Oral Solution, EL (21)A/08

Thame Laboratories are recalling the above batches due to an issue with the container closure (child-resistant cap).

• • Medical specialism: Pharmacy

 Issued: 15 March 2021

• National Patient Safety Alert: Supply disruption of sterile infusion sets and connectors manufactured by Becton Dickinson (BD) (NatPSA/2021/001/MHRA)

BD have notified the MHRA that the sterility of some of their devices cannot be guaranteed due to quality issues with their third-party sterilisation provider.

• • Alert type: National patient safety alert

 Medical specialism: Anaesthetics and 21 others

 

• • • Issued: 11 March 2021

• Class 4 Medicines Defect Information, Diazepam 2mg/5ml Oral Solution Sugar Free (EL (21)A/07) (PL 0142/0103)

Accord-UK Ltd have informed us that important safety warnings for the excipient Propylene glycol are missing from the patient information leaflet (PIL).

• • Medical specialism: Pharmacy

 Issued: 9 March 2021

• Field Safety Notices: 1 to 5 March 2021

List of field safety notices (FSNs) from medical device manufacturers from 1 to 5 March 2021

• • Alert type: Field safety notice

 Issued: 8 March 2021

• Changes to MHRA Drug alert titles and classification

The MHRA has made further changes to the way we issue safety messaging to healthcare providers.

• • • Issued: 1 February 2021

• Field Safety Notices: 22 to 26 February 2021

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

• • Alert type: Field safety notice

 Issued: 1 March 2021

• Class 3 Medicines Recall: Easyhaler Salbutamol Sulfate 100 micrograms per actuation/200 micrograms per actuation inhalation powder, EL (21)A/06

Orion Corporation T/A Orion Pharma (UK) Ltd are recalling specific batches as a precautionary measure due to an issue related to moulding defects in the bulk chambers where the inhalation powder is stored.

• • Medical specialism: Pharmacy

 Issued: 1 March 2021

• Targeted letter: Implantable orthopaedic devices manufactured by Implants International Ltd trading as Xtremity Solutions Ltd. (DSI/2021/002)

Unknown risks following distribution of product after CE certificate withdrawal

• • Alert type: Device safety information

 Medical specialism: Orthopaedics

 Issued: 26 February 2021

• Field Safety Notices: 15 to 19 February 2021

List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 February 2021

• • Alert type: Field safety notice

 Issued: 22 February 2021

• Paclitaxel drug-coated balloons (DCBs) or drug-eluting stents (DESs): Reconfirmed position on use in patients with intermittent claudication and critical limb ischaemia (DSI/2021/001)

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

• • Alert type: Device safety information

 Medical specialism: Cardiology and 2 others

 Issued: 18 February 2021

• Class 3 Medicines Recall: SyriMed, Clonidine hydrochloride 50micrograms/5ml Oral Solution, EL (21)A/05

SyriMed are recalling the below batch as a precautionary measure due to an issue related to the container closure (child-lock cap).

• • Medical specialism: Pharmacy

 Issued: 17 February 2021

• Class 2 Medicines Recall: Eaststone Limited, MidaBuc – Midazolam (as HCL) 10mg/mL Oromucosal Solution, EL (21)A/04

Eaststone Limited has informed us of an issue related to underfilled or empty bottles for MidaBuc – Midazolam (as HCL) 10mg/mL Oromucosal Solution. The below batch is being recalled.

• • Medical specialism: Anaesthetics and 21 others

 Issued: 16 February 2021

• Field Safety Notices: 8 to 12 February 2021

List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 February 2021

• • Alert type: Field safety notice

 Issued: 15 February 2021

• Medical device safety information produced by the MHRA

The MHRA publishes several types of information about medical devices on GOV.UK

• • Alert type: Device safety information

 Issued: 12 February 2021

• Class 4 Medicines Defect Information, AmBisome Liposomal 50 mg Powder for dispersion for infusion, (PL 16807/0001), EL (21)A/03

Gilead Sciences Ltd has informed us of a quality defect issue, in relation to specific lots of 5µm sterile filters, which are co-packed in cartons of the AmBisome product. The medical device is called Minisart Filter 16534-…

• • Medical specialism: Anaesthetics and 21 others

 Issued: 11 February 2021

• Field Safety Notices: 01 to 05 February 2021

List of field safety notices (FSNs) from medical device manufacturers from 01 to 05 February 2021

• • Alert type: Field safety notice

 Issued: 8 February 2021

• Class 2 Medicines Recall: Grünenthal Ltd, Palexia 20 mg/ml Oral Solution (PL 21727/0054)

Grünenthal Ltd has informed us of a potential microbial contamination during routine stability testing for the batches listed in this recall.

• • Medical specialism: General practice and 1 others

 Issued: 8 February 2021

• Class 3 Medicines Recall: Intrapharm Laboratories Ltd, Kolanticon Gel 500ml, EL (21)A/01

Intrapharm Laboratories Ltd has informed us that they have received complaints that the consistency of a batch of Kolanticon Gel 500ml is lumpy. An investigation and retained samples for this batch show the same homogeneity …

• • • Issued: 3 February 2021

• Field Safety Notices: 25 to 29 January 2021

List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 January 2021

• • Alert type: Field safety notice

 Issued: 1 February 2021

• Field Safety Notices: 18 to 22 January 2021

List of field safety notices (FSNs) from medical device manufacturers from 18 January to 22 January 2021

• • Alert type: Field safety notice

 Issued: 26 January 2021

• Company led medicines recall: Respreeza 1,000 mg powder and solvent for solution for infusion (EU/1/15/1006/001)

CSL Behring UK Ltd is recalling specific batches of Respreeza 1,000 mg powder and solvent for solution for infusion (EU/1/15/1006/001) due to a manufacturing deviation that occurred during the filling pro…

• • Medical specialism: Pharmacy

 Issued: 20 January 2021

• Company led medicines recall: Instanyl 100mcg nasal spray solution (EU/1/09/531/015)

Takeda UK Limited is recalling a batch of Instanyl 100mcg nasal spray solution (EU/1/09/531/015) due to the observation of cracked vials during inspection of the bulk vials and release testing of the fini…

• • Medical specialism: Pharmacy

 Issued: 18 January 2021

• Field Safety Notices: 11 to 15 January 2021

List of field safety notices (FSNs) from medical device manufacturers from 11 January to 15 January 2021

• • Alert type: Field safety notice

 Issued: 18 January 2021

• Field Safety Notices: 04 to 08 January 2021

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

 

• • Issued: 11 January 2021