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
1626 JuneMay 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
BeapharJohnson’s DogSmall FleaAnimal Insecticidal Shampoo 125ml and PetsDog withFlea WilkoShampoo Insecticidal200ml Dog shampoo 15/06/202326/05/2023 155552All 375067 3000135 478258batches End User PotentialThe recall is due to a potential quality issue
VersifelClavudale FeLV40 Suspensionmg/10 formg Injectiontablets for Catscats and dogs 13/06/202328/04/2023 665276All in-date batches Vet Level AnStability atypicallyfailure high reporting of the adverseproduct, attributed eventsto already defined within the Summarysuitability of Productthe Characteristicsprimary (SPC)closure
Johnson’sVisqodip Small0.535% Animalw/v InsecticidalReady Shampooto 125mlUse andTeat DogDip Flea Shampoo 200ml Solution 26/05/202313/04/2023 All30718, batches30234, 24915, 24615, 24306, 23943, 23541, 23127, 23010, 22723, 22207, 21605, 20633, 20409, 20318, 20112, 14619, 14148, 13552, 13001, 13110, 13002, 12253, 11716 End User PotentialConcerns qualityregarding issuethe stability of Visqodip when over 12 months old
ClavudalePrednidale 405 mg/10 mg tabletsTablets for- catsProduct anddefect dogsbatch recall alert 28/04/202307/03/2023 All in-date batches136037 Vet Level StabilityPotential failuremould ofcontamination theafter product, attributedopening to the suitability of the primary closurecontainer

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 1626 JuneMay 2023 + show all updates

  1. List of batch recalls updated

  2. Product list updated: Johnson’s Small Animal Insecticidal Shampoo 125ml and Dog Flea Shampoo 200ml Product defect recall added

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

  4. Batch recall for Prednidale 5 mg Tablets added

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

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

  7. Product recall list for last 12 months updated

  8. Update to table of recalled products

  9. Update table of recalled products

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

  11. Salmovac 440 added to list of recalled products

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

  13. Updated to include January 2021 notices

  14. Table of recalled products updated

  15. Updated table of recalled products

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

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

  18. Updated table of recalled products

  19. Updated table of recalled products

  20. Update to the table of recalled products - Clavubactin

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

  22. List of recalled products updated

  23. Updated List of recalled products

  24. Recalled products table updated

  25. Updated list of recalled products

  26. List of recalled products updated

  27. Updated Batch Recall table

  28. Updated Batch Recall table

  29. Updated Batch Recall table.

  30. Updated Batch Recall table

  31. Updated Product Defect Report form

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

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

  34. Batch Recall Table updated

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

  36. Batch Recall table updated

  37. Updated table

  38. Updated recalled product list

  39. Updatded recalled products list

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

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

  42. Product recall list updated

  43. Updated list of recalled products

  44. Updated Recall2 Form

  45. Updated Product defect report form added

  46. Table updated with the latest information

  47. Batch recall table has been updated.

  48. Product recall list updated

  49. First published.

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