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Alerts and recalls for drugs and medical devices

From:
Medicines and Healthcare products Regulatory Agency

724 alerts

724 alerts
  1. Professional use defibrillator/monitor: all HeartStart XL+ (Model number 861290) - risk of failure to deliver therapy (MDA/2020/003)

    Manufactured by Philips – due to hardware or software issues (described in two separate FSNs) the device may fail to start, unexpectedly restart or deliver defibrillation therapy at the wrong energy level.

    • Alert type: Medical device alert
    • Medical specialism: Anaesthetics and 17 others
    • Issued:
  2. Field Safety Notice: 20 to 24 January 2020

    List of field safety notices (FSNs) from medical device manufacturers from 20 January to 24 January 2020

    • Alert type: Field safety notice
    • Medical specialism: General practice and 2 others
    • Issued:
  3. Class 2 Medicines Recall: LEO Laboratories Ltd, Picato 150 mcg/g gel ▼, EU/1/12/796/001, Picato 500 mcg/g gel ▼, EU/1/12/796/002 (EL (20)A/02)

    LEO Laboratories Ltd (T/A LEO Pharma) is recalling all unexpired stock of the above products from pharmacies and wholesalers as a precautionary measure due to concerns on the possible risk of skin malignancy.

    • Alert type: Drug alert
    • Issued:
  4. Field Safety Notice: 13 to 17 January 2020

    List of field safety notices (FSNs) from medical device manufacturers from 13 January to 17 January 2020

    • Alert type: Field safety notice
    • Issued:
  5. Convex two-piece skin barriers (Natura /Surfit/Combihesive Wafers) for use with ostomy bags – recall due to risk of stoma injury, bleeding and leakage under the skin barrier (MDA/2020/002)

    Manufactured by ConvaTec – specific batches of convex two-piece skin barriers have been incorrectly manufactured with off-centre starter/stoma hole.

    • Alert type: Medical device alert
    • Issued:
  6. NIPPY ventilator range (all models) – update to instructions for use (MDA/2020/001

    Manufactured by Breas Medical Limited – maintenance schedule now includes changing the internal memory/alarm battery every 3 years.

    • Alert type: Medical device alert
    • Medical specialism: Anaesthetics and 2 others
    • Issued:
  7. Class 4 Medicines Defect Information: Advanz Pharma Zapain 30mg/500mg Tablets (Codeine Phosphate /Paracetamol), PL12762/0034, (EL(20)A/01)

    Caution in Use: Distribute to Pharmacy level.

    • Alert type: Drug alert
    • Medical specialism: Pharmacy
    • Issued:
  8. Field Safety Notice: 06 to 10 January 2020

    List of field safety notices (FSNs) from medical device manufacturers from 06 to 10 January 2020.

    • Alert type: Field safety notice
    • Issued:
  9. Field Safety Notice: 30 December 2019 to 3 January 2020

    List of field safety notices (FSNs) from medical device manufacturers from 30 December 2019 to 3 January 2020.

    • Alert type: Field safety notice
    • Issued:
  10. 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:
  11. Field Safety Notice: 16 to 20 December 2019

    List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 December 2019.

    • Alert type: Field safety notice
    • Issued:
  12. Arrow EZ-IO intraosseous vascular access needle sets – risk of needle stick injury

    Manufactured by Teleflex Medical (Arrow) – do not use needles if the safety cap is not in place as the risk of needle stick injury is increased and sterility of the needle may be compromised if packaging is punctured.

    • Alert type: Medical device alert
    • Medical specialism: Anaesthetics
    • Issued:
  13. Company led drug alert – Paclitaxel 6 mg/ml concentrate for solution for infusion (25ml vials)

    Hospira UK Limited (Pfizer) is recalling specific batches as a precautionary measure.

    • Alert type: Drug alert: company-led
    • Medical specialism: Pharmacy
    • Issued:
  14. ApexPro telemetry server – risk of loss of alarms for ECG and pulse oximetry monitoring (MDA/2019/045)

    Manufactured by GE – central monitoring station or bedside monitor may not provide visual or audible alarms for ECG arrythmias, lead failures or SpO2 monitoring when used with affected telemetry system.

    • Alert type: Medical device alert
    • Medical specialism: Anaesthetics and 15 others
    • Issued:
  15. Class 2 Medicines Recall: Medley Pharma Limited, Ranitidine 150mg Tablets BP, PL 43870/0026, Ranitidine 300mg Tablets BP, PL 43870/0027 (EL(19)A/41)

    Medley Pharma Limited is recalling all unexpired stock of the below products from pharmacies and retail stores as a precautionary measure.

    • Alert type: Drug alert
    • Medical specialism: General practice and 1 others
    • Issued:
  16. Field Safety Notice: 09 to 13 December 2019

    List of field safety notices (FSNs) from medical device manufacturers from 09 to 13 December 2019.

    • Alert type: Field safety notice
    • Issued:
  17. BritePro Solo and BriteBlade Pro single-use fibre optic laryngoscope blades and handles – risk of choking (MDA/2019/044)

    Manufactured by Flexicare Medical – loose bearings and retaining ring may enter patient’s airway causing choking hazard if the laryngoscope blade is disengaged from the handle above the patient.

    • Alert type: Medical device alert
    • Medical specialism: Anaesthetics and 3 others
    • Issued:
  18. Recall of Medicina IV Luer Slip syringe (IVS03) batch number 19040303 (MDA/2019/043)

    Manufactured by Medicina – syringes incorrectly packaged with a needle could mean they are not sterile and could cause a needlestick injury.

    • Alert type: Medical device alert
    • Medical specialism: Anaesthetics and 20 others
    • Issued:
  19. Field Safety Notice: 02 to 06 December 2019

    List of field safety notices (FSNs) from medical device manufacturers from 02 to 06 December 2019.

    • Alert type: Field safety notice
    • Issued:
  20. Natus gold cup electrodes and snap electrode leads – risk of electric shock

    Manufactured by Natus - GN Otometrics A/S: an exposed conductor may cause an electric shock to the user or patient.

    • Alert type: Medical device alert
    • Issued:
  21. Class 2 Medicines recall: Ranitidine 150mg Film-Coated Tablets, PL 20075/0063, Ranitidine 300mg Film-Coated Tablets, PL 20075/0064 (EL(19)A/40)

    Accord Healthcare are recalling all unexpired stock of the below products from pharmacies and retail stores as a precautionary measure.

    • Alert type: Drug alert
    • Medical specialism: General practice and 1 others
    • Issued:
  22. Spectra Optia apheresis: anticoagulant bags used with ‘Correct Connect’ connectors – risk of unbroken ‘frangible’ connector during use (MDA/2019/041)

    Manufactured by Terumo BCT – inadequately broken anticoagulant ‘frangible’ may lead to clotting and inadequate therapy during apheresis procedures.

    • Alert type: Medical device alert
    • Medical specialism: Anaesthetics and 3 others
    • Issued:
  23. Field Safety Notice: 25 to 29 November 2019

    List of field safety notices (FSNs) from medical device manufacturers from 25 October to 29 November 2019.

    • Alert type: Field safety notice
    • Issued:
  24. Class 2 Medicines recall: Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (EL(19)A/39)

    Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerede Adrenaline Autoinjectors after identifying an error than can cause some pens to fail to activate.

    • Alert type: Drug alert
    • Medical specialism: General practice and 1 others
    • Issued:
  25. Alaris™ Gateway Workstation and Alaris™ Gateway Workstation web browser user interface (MDA/2019/040)

    Manufactured by Becton Dickinson – if a software security vulnerability is exploited, an attacker with malicious intention could remotely install unauthorised firmware.

    • Alert type: Medical device alert
    • Medical specialism: Anaesthetics and 14 others
    • Issued:
  26. Class 2 Medicines Recall: M&A Pharmachem Limited Paracetamol 500 mg Tablets, 1 x 1000, PL 04077/0001, EL(19)A/38

    M&A Pharmachem Limited is recalling all unexpired batches as a precautionary measure, because a small number of pots from some batches have been found to contain discoloured tablets due to fungal contamination.

    • Alert type: Drug alert
    • Medical specialism: Pharmacy
    • Issued:
  27. Field Safety Notice: 18 to 22 November

    List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 November 2019.

    • Alert type: Field safety notice
    • Issued:
  28. Class 2 Medicines recall: Ranitidine 75mg Tablets, (Various Liveries) (EL(19)A/37)

    OTC Concepts Ltd, Relonchem Ltd, Noumed Life Sciences Ltd and Medreich Plc. are recalling stock from pharmacies and retail stores as a precautionary measure due to possible contamination with an impurity.

    • Alert type: Drug alert
    • Medical specialism: General practice and 1 others
    • Issued:
  29. Class 2 Medicines Recall: Ranitidine Oral Solution 30mg/ml, PL 31862/0023, Ranitidine 150mg Tablets, PL 11311/0138 (EL(19)A/36)

    Creo Pharma Limited and Tillomed Laboratories Limited are recalling all unexpired stock of the products listed in this alert.

    • Alert type: Drug alert
    • Medical specialism: General practice and 1 others
    • Issued:
  30. Field Safety Notice: 11 to 15 November

    List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 November 2019.

    • Alert type: Field safety notice
    • Medical specialism: General practice and 1 others
    • Issued:
  31. Class 3 Medicines Recall: Folic Acid Tablets BP 5mg, PL 0142/5522, (EL(19)A/35)

    Accord-UK Ltd has informed us of an issue related to decommissioning of the batch below.

    • Alert type: Drug alert
    • Medical specialism: General practice and 1 others
    • Issued:
  32. Field Safety Notice: 04 to 08 November 2019

    List of field safety notices (FSNs) from medical device manufacturers from 04 to 08 November 2019

    • Alert type: Field safety notice
    • Issued:
  33. Class 2 Medicines Recall: Sandoz Limited, Omeprazole 40 mg Powder for Solution for Infusion, PL 04416/0701 (EL(19)A/34)

    Sandoz Limited is recalling one batch due to the occurrence of degradation in some vials, resulting in green discoloration of the powder in the vial, leading to increased levels of impurities/degradation products in the…

    • Alert type: Drug alert
    • Medical specialism: Pharmacy
    • Issued:
  34. Class 2 Medicines Recall: Kyowa Kirin Limited Mitomycin-C Kyowa, All Strengths (see alert for more information), (EL (19)A/33)

    This recall affects Mitomycin-C Kyowa 2 mg (PL 16508/0042), 10 mg (PL 16508/0043), 20 mg (PL 16508/0044), powder for solution for injection, and Mitomycin-C Kyowa 40 mg (PL 16508/0045), powder for intrave…

    • Alert type: Drug alert
    • Medical specialism: Critical care and 6 others
    • Issued:
  35. Class 2 Medicines Recall: M&A Pharmachem Limited Paracetamol 500 mg Tablets, 1 x 1000, PL 04077/0001, (EL(19)A/32)

    M & A Pharmachem is recalling specific batches as a precautionary measure, because a small number of pots from some batches have been found to contain discoloured tablets due to fungal contamination

    • Alert type: Drug alert
    • Medical specialism: Pharmacy
    • Issued:
  36. Field Safety Notice: 28 October to 1 November

    List of field safety notices (FSNs) from medical device manufacturers from 28 October to 1 November 2019.

    • Alert type: Field safety notice
    • Issued:
  37. Professional use defibrillator/monitor: Efficia DFM100 (Model number 866199) – risk of failure to switch on or unexpected restart (MDA/2019/039)

    Manufactured by Philips – due to a software or hardware issue the device may fail to start or deliver defibrillation therapy.

    • Alert type: Medical device alert
    • Medical specialism: Anaesthetics and 17 others
    • Issued:
  38. Class 2 Medicines Recall: Nutriflex Omega Plus 1250ml, 1875ml and 2500ml, PL 03551/0119, and Nutriflex Omega Special 625ml, 1250ml, 1875ml and 2500ml, PL 03551/0118 and Supplemented Product codes ASNSPOMCA, ASNSPOMSVA, ASNPLOMCA, ASNPLOMSVA (625ml, 1250ml, 1875ml 2500ml) (EL(19)A/31)

    B Braun is initiating a recall of certain batches of the above products as a precautionary measure.

    • Alert type: Drug alert: company-led
    • Issued:
  39. Syringe driver pumps: T34™ 3rd edition models only – stop using the pump until updated instructions for use and BodyCommTM V3.0 software are released (MDA/2019/038)

    Manufactured by CME (a BD company) – the intended operation of these pumps cannot be verified due to errors in the instructions for use (IFUs) and the incompatibility with older versions of BodyComm software (88-102).

    • Alert type: Medical device alert
    • Medical specialism: Care home staff and 3 others
    • Issued:
  40. Field Safety Notice: 21 October to 25 October

    List of field safety notices (FSNs) from medical device manufacturers from 21 October to 25 October

    • Alert type: Field safety notice
    • Issued:
  41. Company led drug alert – Avonex 30 micrograms/0.5ml Solution for Injection

    Biogen Idec UK is recalling batches as a precautionary measure due to a manufacturing issue.

    • Alert type: Drug alert: company-led
    • Medical specialism: Pharmacy
    • Issued:
  42. Class 2 Medicines recall: Zantac 75 Relief Tablets, Zantac 75 Tablets, Galpharm Indigestion Relief 75mg Tablets, Boots Heartburn & Indigestion Relief 75mg Tablets, Kirkland Indigestion Relief 75mg Tablets, Morrisons Indigestion & Heartburn Relief 75mg Tablets, Boots Heartburn & Indigestion Relief 75mg Tablets (EL (19)A/30)

    Omega Pharma Limited and Galpharm International Limited are recalling unexpired stock from pharmacies and retail stores as a precautionary measure due to possible contamination with an impurity.

    • Alert type: Drug alert
    • Medical specialism: General practice and 1 others
    • Issued:
  43. Class 2 Medicines recall: Ranitidine 150mg/10ml Oral Solution (EL (19)A/29)

    Rosemont Pharmaceuticals Limited is recalling unexpired stock from pharmacies as a precautionary measure due to possible contamination with an impurity.

    • Alert type: Drug alert
    • Medical specialism: General practice and 1 others
    • Issued:
  44. Class 2 Medicines recall: Sayana Press 104mg/0.65ml (MDR 055-06/19)

    Pfizer Ltd is recalling certain batches of Sayana Press for subcutaneous injection.

    • Alert type: Drug alert
    • Medical specialism: General practice
    • Issued:
  45. Company led drug alert – Docetaxel Injection 80mg /8ml

    Pfizer UK Limited is recalling batches as routine stability testing has identified that levels of a known impurity, 10-oxo-docetaxel, may exceed the acceptable level at end of shelf-life.

    • Alert type: Drug alert: company-led
    • Issued:
  46. Field Safety Notice: 14 October to 18 October

    List of field safety notices (FSNs) from medical device manufacturers from 14 October to 18 October

    • Alert type: Field safety notice
    • Issued:
  47. Class 2 Medicines recall: Ranitidine Effervescent Tablets 150mg, Ranitidine Effervescent Tablets 300mg (EL (19)A/27)

    Teva UK Limited trading as ratiopharm GmbH is recalling all unexpired stock of Ranitidine Effervescent Tablets from pharmacies.

    • Alert type: Drug alert
    • Medical specialism: General practice and 1 others
    • Issued:
  48. Class 4 Medicines Defect Information: Xonvea 10 mg/10 mg gastro-resistant tablets (MDR 025-10/19)

    Alliance Pharmaceuticals Ltd has informed the MHRA that there are possible side effects not reported on the Patient Information Leaflet.

    • Alert type: Drug alert
    • Medical specialism: General practice and 1 others
    • Issued:
  49. Class 4 Medicines Defect Information: Rifadin (rifampicin) 150mg Capsules (MDR 127-09/19)

    Aventis Pharma Limited t/a Sanofi has informed the MHRA that a change to the Patient Information Leaflet concerning possible side effects for Rifadin (rifampicin) 150mg Capsules has not been implemented by the required …

    • Alert type: Drug alert
    • Medical specialism: General practice and 1 others
    • Issued:
  50. Field Safety Notice: 7 October to 11 October

    List of field safety notices (FSNs) from medical device manufacturers from 7 October to 11 October

    • Alert type: Field safety notice
    • Issued: