Guidance

Report a product defect: veterinary medicine

How a marketing authorisation holder should report a defect with a veterinary medicine.

From:
Veterinary Medicines Directorate
Published
17 November 2014
Last updated
92 MarchMay 2023 — See all updates

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
Clavudale 40 mg/10 mg tablets for cats and dogs 28/04/2023All in-date batchesVet LevelStability failure of the product, attributed to the suitability of the primary closure
Visqodip 0.535% w/v Ready to Use Teat Dip Solution 13/04/202330718, 30234, 24915, 24615, 24306, 23943, 23541, 23127, 23010, 22723, 22207, 21605, 20633, 20409, 20318, 20112, 14619, 14148, 13552, 13001, 13110, 13002, 12253, 11716End UserConcerns regarding the stability of Visqodip when over 12 months old
Prednidale 5 mg Tablets - Product defect batch recall alert 07/03/2023 136037 Vet Level Potential 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 18/07/22All batches on the marketVet LevelParticulate 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 92 MarchMay 2023 + show all updates

  1. Product defect recall added for Clavudale 40 mg/10 mg tablets for cats and dogs

  2. Batch recall for Prednidale 5 mg Tablets added

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

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

  5. Product recall list for last 12 months updated

  6. Update to table of recalled products

  7. Update table of recalled products

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

  9. Salmovac 440 added to list of recalled products

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

  11. Updated to include January 2021 notices

  12. Table of recalled products updated

  13. Updated table of recalled products

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

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

  16. Updated table of recalled products

  17. Updated table of recalled products

  18. Update to the table of recalled products - Clavubactin

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

  20. List of recalled products updated

  21. Updated List of recalled products

  22. Recalled products table updated

  23. Updated list of recalled products

  24. List of recalled products updated

  25. Updated Batch Recall table

  26. Updated Batch Recall table

  27. Updated Batch Recall table.

  28. Updated Batch Recall table

  29. Updated Product Defect Report form

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

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

  32. Batch Recall Table updated

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

  34. Batch Recall table updated

  35. Updated table

  36. Updated recalled product list

  37. Updatded recalled products list

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

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

  40. Product recall list updated

  41. Updated list of recalled products

  42. Updated Recall2 Form

  43. Updated Product defect report form added

  44. Table updated with the latest information

  45. Batch recall table has been updated.

  46. Product recall list updated

  47. First published.

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