Guidance

Report a product defect: veterinary medicine

How a marketing authorisation holder should 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, 38.6 KB) 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, for example wholesaler level, veterinary practice level.

All other reporters should contact the marketing authorisation holder.

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.

Product Notification Date Batch No. Level of Recall Problem
Prednidale 5 mg Tablets - Product defect batch recall alert 07/03/2023136037Vet LevelPotential mould contamination after opening of the primary container
Flukiver 5% w/v Oral Suspension - product defect batch recall alert 10/02/2023 22FQ211 Wholesaler Level The lot number on this batch is incorrect
Product defect batch recall alert Baytril Piglet Doser 0.5% Oral Solution 02/02/2023 KV045EX Wholesaler Level The expiry date on this batch is incorrect
Product defect recall alert for Anesketin 100 mg/ml solution for injection for dogs, cats and horses 06/01/2023 140461 Vet Level A compromised closure of the vials
Nerfasin 20 mg/ml Solution for Injection for Cattle, Horses, Dogs and Cats Product defect recall alert 18/07/22 All batches on the market Vet Level Particulate matter found in retained samples that were previously particle free

What issues are classed as a product defect

These include:

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

Further information on how the VMD handles product defect reports.

Legal requirement

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 139 FebruaryMarch 2023 + show all updates
  1. Batch recall for Prednidale 5 mg Tablets added

  2. Product added: Flukiver 5% w/v Oral Suspension - product defect batch recall alert

  3. Product defect batch recall alert Baytril Piglet Doser 0.5% Oral Solution added.

  4. Product recall list for last 12 months updated

  5. Update to table of recalled products

  6. Update table of recalled products

  7. Updated table of recalled products: Lydaxx 100 mg/ml solution for injection for cattle, pigs and sheep Ketofen 10% Solution for Injection

  8. Salmovac 440 added to list of recalled products

  9. Product defect recall alert added for Prid Delta 1.55 g Vaginal Delivery System for Cattle.

  10. Updated to include January 2021 notices

  11. Table of recalled products updated

  12. Updated table of recalled products

  13. Added Johnson’s 4Fleas 80mg Spot-on Solution for Cats to table of recalled products

  14. Added Foston 20% w/v Solution for Injection - Product defect recall alert

  15. Updated table of recalled products

  16. Updated table of recalled products

  17. Update to the table of recalled products - Clavubactin

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

  19. List of recalled products updated

  20. Updated List of recalled products

  21. Recalled products table updated

  22. Updated list of recalled products

  23. List of recalled products updated

  24. Updated Batch Recall table

  25. Updated Batch Recall table

  26. Updated Batch Recall table.

  27. Updated Batch Recall table

  28. Updated Product Defect Report form

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

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

  31. Batch Recall Table updated

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

  33. Batch Recall table updated

  34. Updated table

  35. Updated recalled product list

  36. Updatded recalled products list

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

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

  39. Product recall list updated

  40. Updated list of recalled products

  41. Updated Recall2 Form

  42. Updated Product defect report form added

  43. Table updated with the latest information

  44. Batch recall table has been updated.

  45. Product recall list updated

  46. First published.