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. Problem
29 August 2019 Isathal 10mg/g eye drops suspension for dogs, cats and rabbits A72346 Out of specification result for particle size being found in routine stability testing.
21 June 2019 Alfaxan & Alfaxan Multidose 10mg/ml Solution for Injection 55523 48317 62816 Particulates found in identified batches of product during routine stability testing program.
17 May 2019 Norfenicol 300mg/ml Solution for Injection 9054-91B Failed periodic revalidation (media fill test) that may affect the level of sterility assurance of certain products.
15 May 2019 Tylan 200mg/ml Solution for Injection C967336A Failed periodic revalidation (media fill test) that may affect the level of sterility assurance of certain products.
28 March 2019 Anaestamine 100mg/ml injection All batches Particles found in the vials of the product.
17 January 2019 Equimax Oral Gel for Horses Yardpacks 80126 80931 Packs of 48 syringes each containing 7.49 g of product are being recalled with immediate effect, as they do not contain English language package leaflets and the immediate packaging (sticker on dosing syringe) is not in English.
30 November 2018 Carprieve Small Animal Injection 8254-90G Sterility not assured.
20 July 2018 Willcain Solution for Injection 92927 94340 94341 106023 106024 106025 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 5 September 2019 + show all updates
  1. Recall notification for Isathal 10mg/g eye drops added
  2. List of recalled products updated
  3. Updated List of recalled products
  4. Recalled products table updated
  5. Updated list of recalled products
  6. List of recalled products updated
  7. Updated Batch Recall table
  8. Updated Batch Recall table
  9. Updated Batch Recall table.
  10. Updated Batch Recall table
  11. Updated Product Defect Report form
  12. Updated Analysis of Quality Product Defects received by the VMD in 2016-17 Report
  13. Oxytobel 10IU/ml added to the list of recalled products.
  14. Batch Recall Table updated
  15. Added link to analysis of reports received by the VMD in 2016-17
  16. Batch Recall table updated
  17. Updated table
  18. Updated recalled product list
  19. Updatded recalled products list
  20. Product Defect/Batch Recall Report Template (Recall 2) with the latest version
  21. Propofol Emulsion for Injection 1.0% w/v added to the recall table
  22. Product recall list updated
  23. Updated list of recalled products
  24. Updated Recall2 Form
  25. Updated Product defect report form added
  26. Table updated with the latest information
  27. Batch recall table has been updated.
  28. Product recall list updated
  29. First published.