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Alerts and recalls for drugs and medical devices

From:
Medicines and Healthcare products Regulatory Agency

804 alerts

804 alerts
  1. Class 3 Medicines Recall: Accord-UK Ltd, Digoxin Tablets BP 250 micrograms, EL (20)A/35

    Accord-UK Ltd has informed us of an issue related to decommissioning of a specific batch

    • Alert type: Drug alert
    • Medical specialism: Pharmacy
    • Issued:
  2. Class 2 Medicines Recall: Kyowa Kirin Limited, Abstral 200 microgram sublingual tablets, EL (20)A/34

    Kyowa Kirin Limited is recalling a specific batch as a precautionary measure, due to the reports of double tablets in a single blister pocket.

    • Alert type: Drug alert
    • Medical specialism: Pharmacy
    • Issued:
  3. Field Safety Notices - 20 July - 24 July 2020

    Summary list of field safety notices (FSNs) from medical device manufacturers from 20 July to 24 July 2020

    • Alert type: Field safety notice
    • Issued:
  4. Class 3 Medicines Recall: Accord Healthcare Limited, Irinotecan Hydrochloride Concentrate for Solution for Infusion 20mg/ml (5ml vial), EL (20)A/33

    Accord Healthcare Limited is recalling the above batch as a precautionary measure, due to the observation of precipitation in the solution in the same batch marketed in another country (Malta).

    • Alert type: Drug alert
    • Medical specialism: Pharmacy
    • Issued:
  5. Philips sterilizable defibrillator internal paddles (specific models) – may fail to deliver therapy if pre-use checks are not followed (MDA/2020/022)

    Manufactured by Philips – defibrillator internal paddles may wear over time and might fail to deliver therapy, so it is important to do routine operational checks between each usage.

    • Alert type: Medical device alert
    • Medical specialism: Cardiology and 2 others
    • Issued:
  6. Class 4 Medicines Defect Information: Pfizer Limited, Ecalta 100mg powder for concentrate for solution for infusion, EL (20)A/32

    Pfizer Limited has informed us that the packs for the affected batches below have not been packaged with the current version of the Patient Information Leaflet (PIL) containing updated storage instructions of the infusion so…

    • Alert type: Drug alert
    • Medical specialism: Pharmacy
    • Issued:
  7. Field Safety Notices - 13 July to 17 July 2020

    Summary list of field safety notices (FSNs) from medical device manufacturers from 13 July to 17 July 2020

    • Alert type: Field safety notice
    • Issued:
  8. Class 4 Medicines Defect Information: Ennogen Pharma Limited, Trimogal 100mg and 200mg Tablets, EL (20)A/31

    Ennogen Pharma Limited has informed us that the Patient Information Leaflets (PILs) within the packs for the affected batches below contain an error in Section 3 (How To Take Trimogal Tablets) with regard to the dosage instr…

    • Alert type: Drug alert
    • Medical specialism: Pharmacy
    • Issued:
  9. Masks: type IIR from Cardinal Health – destroy affected lots (MDA/2020/021)

    Foam strip on the mask can flake and enter the wearer’s airway or mouth; ties and/or stitching may detach from the mask.

    • Alert type: Medical device alert
    • Medical specialism: Anaesthetics and 16 others
    • Issued:
  10. Class 4 Medicines Defect Information: Aspar Pharmaceuticals Limited, Ibuprofen 200mg and 400mg tablets packaged in various liveries, EL (20)A/30

    Aspar Pharmaceuticals Limited has informed us that the Patient Information Leaflets (PILs) within the ibuprofen packs below are missing some information identified from post-marketing experience that should be documented in …

    • Alert type: Drug alert
    • Medical specialism: Pharmacy
    • Issued:
  11. Class 2 Medicines Recall: Ferring Pharmaceuticals Limited, desmopressin nasal spray (all strengths), PL 03194/0024, PL 03194/0090, PL 03194/0056, EL (20)A/29

    Ferring Pharmaceuticals Limited is recalling all unexpired stock of the products below from pharmacies and wholesalers as a precautionary measure due to a lower volume of solution being observed in the bottles, and out of sp…

    • Alert type: Drug alert
    • Medical specialism: Pharmacy
    • Issued:
  12. Class 2 Medicines Recall: Nitrofurantoin 50 mg Tablets, PL 08553/0087, EL (20)A/28

    Dr Reddy’s Laboratories (UK) Limited is recalling all unexpired stock of a specific batch of Nitrofurantoin 50mg Tablets from pharmacies and wholesalers as a precautionary measure due to out of specification results for diss…

    • Alert type: Drug alert
    • Medical specialism: Pharmacy
    • Issued:
  13. Field Safety Notices - 06 July to 10 July 2020

    Summary list of field safety notices (FSNs) from medical device manufacturers from 06 July to 10 July 2020

    • Alert type: Field safety notice
    • Issued:
  14. Spinal fixation system – risk of implant failure prior to completion of bone healing (MDA/2020/020)

    Manufactured by Synthes GmbH – cracking of the USS II Polyaxial 3D Head rings may result in loosening of the fixation system prior to completion of bone healing.

    • Alert type: Medical device alert
    • Medical specialism: Orthopaedics
    • Issued:
  15. Field Safety Notices - 29 June to 03 July 2020

    Summary list of field safety notices (FSNs) from medical device manufacturers from 29 June to 03 July 2020

    • Alert type: Field safety notice
    • Issued:
  16. Abbott Trifecta / Trifecta GT bioprosthetic aortic heart valves: cases of structural valve deterioration (SVD) (MDA/2020/019)

    Manufactured by Abbott – cases of valvular insufficiency and early revision.

    • Alert type: Medical device alert
    • Medical specialism: Cardiology and 2 others
    • Issued:
  17. Class 2 Medicines Recall: Mepacrine Hydrochloride 100 mg Tablets (Batch 85641), EL (20)A/27

    BCM Specials Limited is recalling a specific batch of Mepacrine Hydroxychloride 100 mg tablets due to a number of foreign body particulates found in the containers of the API used to make it.

    • Alert type: Drug alert
    • Medical specialism: Pharmacy
    • Issued:
  18. Class 4 Medicines Defect Information: Depo-Provera 150mg/ml Injection (1ml Vial) EL (20)A/26

    Drugsrus Ltd (distributor) / Tenolol Ltd (MA Holder) has informed us of a typographical error in active ingredient stated on the label on the vial.

    • Alert type: Drug alert
    • Medical specialism: Pharmacy
    • Issued:
  19. Philips HeartStart XL Defibrillator/Monitor – therapy selector switch may fail (MDA/2020/018)

    Manufactured by Philips – the rotary therapy selector switch may fail resulting in unexpected device behaviours which could lead to a delay or failure in delivering therapy.

    • Alert type: Medical device alert
    • Medical specialism: Anaesthetics and 15 others
    • Issued:
  20. Field Safety Notices - 22 June to 26 June 2020

    Summary list of field safety notices (FSNs) from medical device manufacturers from 22 June to 26 June 2020

    • Alert type: Field safety notice
    • Issued:
  21. Philips Respironics V60 ventilator – potential unexpected shutdown leading to complete loss of ventilation (MDA/2020/017)

    Manufactured by Philips Respironics – sudden loss of power due to component failure, which may not always be accompanied by an alarm or visual warning.

    • Alert type: Medical device alert
    • Medical specialism: Anaesthetics and 2 others
    • Issued:
  22. Field Safety Notices - 15 to 19 June 2020

    Summary list of field safety notices (FSNs) from medical device manufacturers from 15 to 19 June 2020

    • Alert type: Field safety notice
    • Issued:
  23. Philips HeartStart MRx Monitor/Defibrillators - may fail to deliver therapy without alerting the user to a fault in the event of internal damage (MDA/2020/016)

    The Philips HeartStart MRx Monitor/Defibrillator MRx may fail to identify a fault and alert the user in the event of internal damage suffered during a drop or due to severe mechanical shock.

    • Alert type: Medical device alert
    • Medical specialism: Anaesthetics and 18 others
    • Issued:
  24. Field Safety Notices - 08 to 12 June 2020

    Summary list of field safety notices (FSNs) from medical device manufacturers from 08 to 12 June 2020

    • Alert type: Field safety notice
    • Issued:
  25. Field Safety Notices - 01 to 05 June 2020

    Summary list of field safety notices (FSNs) from medical device manufacturers from 01 to 05 May 2020

    • Alert type: Field safety notice
    • Issued:
  26. Class 2 Medicines Recall: Epistatus (Midazolam) 10mg/mL Oromucosal Solution (Multi Dose Bottles), EL (20)A/25

    Torbay Pharmaceuticals is recalling specific batches of Epistatus (Midazolam) 10mg/mL Oromucosal Solution (Multi Dose Bottles) due to a potentially faulty and incorrectly engaged child-resistant container closure.

    • Alert type: Drug alert
    • Medical specialism: Pharmacy
    • Issued:
  27. Results from laboratory-based tests for COVID-19 antibodies using capillary blood sample collection kits may not be reliable (MDA/2020/015)

    This covers issues with both laboratory based tests for COVID-19 antibodies (unvalidated sample type) and capillary blood sample collection kits (unvalidated for home use)

    • Alert type: Medical device alert
    • Medical specialism: Care home staff and 3 others
    • Issued:
  28. Field Safety Notices - 27 to 29 May 2020

    Summary list of field safety notices (FSNs) from medical device manufacturers from 27 to 29 May 2020

    • Alert type: Field safety notice
    • Issued:
  29. Field Safety Notices - 18 to 22 May 2020

    Summary list of field safety notices (FSNs) from medical device manufacturers from 18 to 22 May 2020

    • Alert type: Field safety notice
    • Issued:
  30. Class 4 Medicines Defect Information: Sodium Benzoate (Amzoate) 2g in 10 mL Sterile Solution for injection, EL (20)A/24

    Torbay Pharmaceuticals has informed us that the carton label on Sodium Benzoate (Amzoate) 2g in 10 mL Sterile Solution for injection incorrectly states the concentration of disodium edetate (excipient) as 0.1% w/v (10mg…

    • Alert type: Drug alert
    • Medical specialism: Pharmacy
    • Issued:
  31. Company led drug alert - Duavive (conjugated oestrogen/bazedoxifene acetate) 0.45mg/20mg Modified Release Tablets – EU/1/14/960/001

    As a precautionary measure, Pfizer Limited is recalling the above batches from wholesalers due to out of specification results from the ongoing stability studies.

    • Alert type: Drug alert: company-led
    • Medical specialism: Pharmacy
    • Issued:
  32. Field Safety Notices - 11 to 15 May 2020

    Summary list of field safety notices (FSNs) from medical device manufacturers from 11 to 15 May 2020

    • Alert type: Field safety notice
    • Issued:
  33. Class 2 Medicines Recall: Emerade 500 micrograms solution for injection in pre-filled syringe, PL 33616/0015 (EL(20)A/23

    Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 500 microgram auto-injectors (also referred to as pens) from patients due to an error in one com…

    • Alert type: Drug alert
    • Medical specialism: Care home staff and 5 others
    • Issued:
  34. Field Safety Notices - 4 to 8 May 2020

    Summary list of field safety notices (FSNs) from medical device manufacturers from 4 to 8 May 2020

    • Alert type: Field safety notice
    • Issued:
  35. Field Safety Notices - 27 April to 1 May 2020

    Summary list of field safety notices (FSNs) from medical device manufacturers from 27 April to 1 May 2020

    • Alert type: Field safety notice
    • Issued:
  36. Field Safety Notices - 20 to 24 April 2020

    Summary list of field safety notices (FSNs) from medical device manufacturers from 20 to 24 April 2020

    • Alert type: Field safety notice
    • Issued:
  37. Field Safety Notices - 13 to 17 April 2020

    Summary list of field safety notices (FSNs) from medical device manufacturers from 13 to 17 April 2020

    • Alert type: Field safety notice
    • Issued:
  38. Class 4 Medicines Defect Information: Glaxosmithkline Consumer Healthcare (UK) Trading Limited, various products, EL(20)A/22

    GSK has informed us that due to a machinery defect with the printing line, a small number of packs may not have the batch number and expiry date printed on the outer cartons.

    • Alert type: Drug alert
    • Medical specialism: Pharmacy
    • Issued:
  39. Pilling Clear Advantage aortic punch – risk of infection due to packaging failure (MDA/2020/014)

    Manufactured by Teleflex – if the packaging is not intact, the device won’t be sterile.

    • Alert type: Medical device alert
    • Medical specialism: Cardiology and 2 others
    • Issued:
  40. Class 4 Medicines Defect Information: Levofloxacin 500mg Tablets, PL 00289/1047 EL (20)A/21

    TEVA UK Limited has informed us that the Product Code/GTIN (PC) number found on the below batches is incorrect.

    • Alert type: Drug alert
    • Medical specialism: Pharmacy
    • Issued:
  41. Field Safety Notices - 6 to 9 April 2020

    Summary list of field safety notices (FSNs) from medical device manufacturers from 6 to 9 April 2020

    • Alert type: Field safety notice
    • Issued:
  42. COVID-19: All haemofiltration systems including machines and accessories – serious risks if users don’t follow manufacturer instructions for set-up (MDA/2020/013)

    All manufacturers – there have been reports of off-label modifications to haemofiltration systems when treating Covid-19 patients leading to serious injury and death.

    • Alert type: Medical device alert
    • Medical specialism: Anaesthetics and 3 others
    • Issued:
  43. Anaesthetic machines: off-label use during the COVID-19 pandemic (MDA/2020/012)

    All anaesthesia machines with ventilators - using the anaesthesia device in treatment of critical illness, outside its intended use is considered off-label use but may be essential due to ventilator availability.

    • Alert type: Medical device alert
    • Medical specialism: Anaesthetics and 2 others
    • Issued:
  44. Class 2 Medicines Recall: Emerade 300 micrograms solution for injection in pre-filled syringe, PL 33616/0014 (EL(20)A/20)

    Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 300 microgram auto-injectors (also referred to as pens) from patients due to an error in one com…

    • Alert type: Drug alert
    • Medical specialism: Care home staff and 5 others
    • Issued:
  45. Field Safety Notices - 30 March to 3 April 2020

    Summary list of field safety notices (FSNs) from medical device manufacturers from 30 March to 3 April 2020

    • Alert type: Field safety notice
    • Issued:
  46. Spinal implant: All MAGEC Systems – supply suspended to the UK (MDA/2020/011)

    Manufactured by NuVasive Specialized Orthopedics – supply of all MAGEC rods suspended to the UK market during a review by MHRA.

    • Alert type: Medical device alert
    • Medical specialism: Orthopaedics and 2 others
    • Issued:
  47. Field Safety Notices - 23 to 27 March 2020

    Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 March 2020

    • Alert type: Field safety notice
    • Issued:
  48. Class 4 Medicines Defect Information: Rosemont Pharmaceuticals Ltd, Paracetamol 250mg/5ml Oral Suspension (500ml) PL 00427/0078 EL (20)A/19

    Rosemont Pharmaceuticals Ltd has informed us of an error in the barcode and GTIN number of the label on the bottle of the below batches.

    • Alert type: Drug alert
    • Medical specialism: Pharmacy
    • Issued:
  49. Class 4 Medicines Defect Information: Zamadol SR 50 mg prolonged-release hard capsules, PL 46302/0149 (EL (20)A/18)

    Mylan UK Healthcare Ltd has informed us that the GTIN barcode applied on the below batches is incorrect.

    • Alert type: Drug alert
    • Medical specialism: Pharmacy
    • Issued:
  50. Field Safety Notices - 16 to 20 March 2020

    Summary List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 March 2020

    • Alert type: Field safety notice
    • Issued: