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Alerts and recalls for drugs and medical devices

From:
Medicines and Healthcare products Regulatory Agency

742 alerts

742 alerts
  1. All T34 and T34L (T60) ambulatory syringe pumps – check pumps before each use due to risk of under-infusion and no alarm (MDA/2020/007)

    Manufactured by CME (a BD company) – updated advice to address ‘wear and tear’ of the syringe pump motor block which may lead to under-infusion.

    • Alert type: Medical device alert
    • Medical specialism: Care home staff and 1 others
    • Issued:
  2. Class 4 Medicines Defect Information: Memantine 10mg Film-Coated Tablets, PL 20416/0260, (EL (20)A/11)

    Crescent Pharma Ltd has informed us of a discrepancy on the product packaging.

    • Alert type: Drug alert
    • Issued:
  3. Class 4 Drug Alert: Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd, Ibuprofen 400mg Tablets, (EL (20)A/10)

    Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd have informed us that the Patient Information Leaflet (PIL) within their packs for the above pharmacy (P) batches is incorrect.

    • Alert type: Drug alert
    • Medical specialism: Pharmacy
    • Issued:
  4. Field Safety Notices - 17 to 21 February 2020

    Summary List of field safety notices (FSNs) from medical device manufacturers from 17 to 21 February 2020

    • Alert type: Field safety notice
    • Issued:
  5. Field Safety Notices - 10 to 14 February 2020

    Summary List of field safety notices (FSNs) from medical device manufacturers from 10 to 14 February 2020

    • Alert type: Field safety notice
    • Issued:
  6. Class 4 FMD Medicines Defect Information: Diamorphine Hydrochloride BP 100 mg Lyophilisate for Solution for Injection, PL 20075/0675, (EL (20)A/09)

    Accord Healthcare Ltd has informed us of an issue related to the expiry date for the above batches, which has not been encoded in 2D data matrix.

    • Alert type: Drug alert
    • Issued:
  7. Self-expanding stents (S.M.A.R.T. and PRECISE) under MRI – various risks if MRI is operated outside the required conditions for these stents (MDA/2020/006)

    Manufactured by Cordis – instructions for use contain incorrect MRI compatibility information.

    • Alert type: Medical device alert
    • Medical specialism: Anaesthetics and 6 others
    • Issued:
  8. Class 2 Medicines recall: Accord-UK Ltd, Gliclazide 40 mg Tablets (Northstar Livery), PL 20075/0687, (EL (20)A/08)

    Accord-UK Limited is recalling all unexpired stock of Gliclazide 40 mg Tablets (Northstar Livery) from pharmacies and wholesalers as a precautionary measure due to out of specification results for dissolution, obtained durin…

    • Alert type: Drug alert
    • Medical specialism: Pharmacy
    • Issued:
  9. Class 3 FMD Medicines Recall, Beconase Aqueous Nasal Spray, (Beclometasone Dipropionate 50μg), PL 10949/0104, EL (20)A/07

    Glaxo Wellcome UK Ltd T/A GSK has informed us of an issue related to error in the decommissioning of the K84X batch.

    • Alert type: Drug alert
    • Medical specialism: Pharmacy
    • Issued:
  10. Class 4 Medicines Defect Information: Atrolak XL Prolonged-release tablets, all strengths (quetiapine fumarate)

    Accord Healthcare Ltd has informed us that the Patient Information Leaflet (PIL) for all strengths of Atrolak XL Prolonged-release tablets is missing the side effects identified from post-marketing experience.

    • Alert type: Drug alert
    • Medical specialism: Pharmacy
    • Issued:
  11. Field Safety Notices - 3 to 7 February 2020

    Summary List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 February 2020

    • Alert type: Field safety notice
    • Issued:
  12. Company led drug alert – Iohexol solution for injection (350mg/ml and 300 mgI/ml)

    Glenmark Pharmaceuticals is recalling specific batches as a precautionary measure.

    • Alert type: Drug alert: company-led
    • Medical specialism: Pharmacy
    • Issued:
  13. t:slim X2 insulin pump – discard or destroy defective mains (A/C) power adapters (MDA/2020/005)

    Manufactured by Tandem Diabetes Care – an exposed component may cause an electrical shock to the user or patient

    • Alert type: Medical device alert
    • Medical specialism: Care home staff and 2 others
    • Issued:
  14. Skin preparation electrode gel: recall of all lots of LemonPrep, PediaPrep, Wave Prep and Cardio Prep due to risk of contamination and transmission of infection (MDA/2020/004)

    Manufactured by Mavidon – products may be contaminated with the microorganism Burkholderia cepacia leading to an infection risk to patients.

    • Alert type: Medical device alert
    • Medical specialism: Anaesthetics and 17 others
    • Issued:
  15. Field Safety Notice: 27 to 31 January

    List of field safety notices (FSNs) from medical device manufacturers from 27 January to 31 January 2020.

    • Alert type: Field safety notice
    • Issued:
  16. Class 2 Medicines recall: Medreich PLC, Ranitidine 150mg Tablets, PL 21880/0091, Ranitidine 300mg Tablets, PL 21880/0092 (EL (20)A/05)

    Medreich Plc is recalling all unexpired stock of the above products from pharmacies and wholesalers as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic …

    • Alert type: Drug alert
    • Issued:
  17. Class 2 Medicines Recall: Wockhardt UK Ltd, Levothyroxine 100micrograms/5ml Oral Solution EL(20)A/04

    Wockhardt UK Ltd is recalling specific batches of Levothyroxine 100micrograms/5ml Oral Solution from pharmacies and wholesalers as a precautionary measure due to notification of the impurity liothyronine exceeding the s…

    • Alert type: Drug alert
    • Medical specialism: General practice and 1 others
    • Issued:
  18. Class 4 Medicines Defect Information: Dr. Reddy's Laboratories (UK) Ltd, Finasteride 5mg Tablets, PL 08553/0261 (EL (20)A/03)

    Dr Reddy's Laboratories (UK) Ltd has informed us that the Patient Information Leaflet (PIL) for the specific batches listed in this alert are missing the special warning and precautions identified from post-marketing ex…

    • Alert type: Drug alert
    • Issued:
  19. 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:
  20. 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:
  21. 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:
  22. 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:
  23. 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:
  24. 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:
  25. 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:
  26. 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:
  27. 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:
  28. 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:
  29. 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:
  30. 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:
  31. 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:
  32. 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:
  33. 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:
  34. 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:
  35. 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:
  36. 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:
  37. 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:
  38. 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:
  39. 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:
  40. 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:
  41. 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:
  42. 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:
  43. 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:
  44. 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:
  45. 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:
  46. 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:
  47. 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:
  48. 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:
  49. 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:
  50. 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: