Guidance

Report a product defect: veterinary medicine

For a marketing authorisation holder only; how to report a defect with a veterinary medicine.

Reporting a product defect

If a pharmaceutical company becomes aware of an issue or defect with one of their products or a batch of product they must report this to the Veterinary Medicines Directorate (VMD).

Complete the Product defect report form (ODT, 38.7KB) and send it to rapidalert@vmd.gov.uk.

If the product or batch is likely to be recalled due to the defect you must contact the VMD to discuss the issue. Where appropriate give details of the level of recall, e.g. wholesaler level, veterinary practice level.

Do not use this form to report an adverse event to a veterinary medicine or microchip; To report a suspected adverse event.

List of recalled products

Products recalled in the UK in the last 12 months.

Notification Date Product Batch No. Level of Recall Problem
24 January 2020 Clavubactin 50/12.5mg, 250/62.5mg, 500/125mg - Product defect recall alert 19D82 18D11 18G32 19D83 17F46 17H35 18D13 19D88 17C80 17F47 17H38 18D17 18D18 18G34 Vet level During routine stability testing, the products mentioned do not fulfil the mandatory testing requirements at 24 months. This recall is because the efficacy of the product cannot be guaranteed after 12 months.
20 December 2019 Synulox Lactating Cow Intramammary Suspension - Product defect recall alert 91939702 81950600 81958301 81962601 81966700 81968102 81968300 91927402 91938601 91938700 91954001 End user Following the recent SNC for Farmabios (SNC2019 048), batches of this product containing API that is impacted by this non-compliance statement are being recalled from the market as a precaution.
17 May 2019 Norfenicol 300mg/ml Solution for Injection 9054-91B Vet level Failed periodic revalidation (media fill test) that may affect the level of sterility assurance of certain products.
30 November 2018 Carprieve Small Animal Injection 8254-90G Vet level Sterility not assured.
20 July 2018 Willcain Solution for Injection 92927 94340 94341 106023 106024 106025 Vet level Low active substance assay results during long term stability trial

What issues are classed as a product defect?

These would include:

  • incorrect labelling (e.g. product strength, name of ingredients)
  • misinformation or lack of information on the packaging or leaflets
  • incorrect manufacture (e.g. strength of the ingredients or an issue with the container)
  • contamination of any kind
  • stability (e.g. expiry)
  • counterfeit or deliberately tampered with product

Further information on how VMD handles product defect reports can be found in Analysis of reports received by the VMD in 2016-17 (PDF, 236KB, 7 pages).

The holder of an authorisation referred to in Article 44 of Directive 2001/82/EC (for veterinary products) is required by Article 13 of Directive 91/412/EEC (for veterinary products) to implement an effective procedure for the recall of defective products. The authorisation holder is required to notify the relevant Competent Authority of any defect that could result in a recall and indicate, as far as possible, the countries of destination of the defective product.

For information on human medicines please visit the MHRA Safety Information page.

Contact

rapidalert@vmd.gov.uk

Alternatively phone the Inspections team via the switchboard on, 01932 336911.

Published 17 November 2014
Last updated 29 January 2020 + show all updates
  1. Update to the table of recalled products - Clavubactin

  2. Recall notification for Isathal 10mg/g eye drops added

  3. List of recalled products updated

  4. Updated List of recalled products

  5. Recalled products table updated

  6. Updated list of recalled products

  7. List of recalled products updated

  8. Updated Batch Recall table

  9. Updated Batch Recall table

  10. Updated Batch Recall table.

  11. Updated Batch Recall table

  12. Updated Product Defect Report form

  13. Updated Analysis of Quality Product Defects received by the VMD in 2016-17 Report

  14. Oxytobel 10IU/ml added to the list of recalled products.

  15. Batch Recall Table updated

  16. Added link to analysis of reports received by the VMD in 2016-17

  17. Batch Recall table updated

  18. Updated table

  19. Updated recalled product list

  20. Updatded recalled products list

  21. Product Defect/Batch Recall Report Template (Recall 2) with the latest version

  22. Propofol Emulsion for Injection 1.0% w/v added to the recall table

  23. Product recall list updated

  24. Updated list of recalled products

  25. Updated Recall2 Form

  26. Updated Product defect report form added

  27. Table updated with the latest information

  28. Batch recall table has been updated.

  29. Product recall list updated

  30. First published.