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, 38.6KB) 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
16 April 2020 Foston 20% w/v Solution for Injection - Product defect recall alert A121A A122A A123A wholesaler level In the course of an internal review, it was noted that the available data for the product Foston 20% w/v Solution for Injection no longer meets the current EU regulations for food-producing species.
05 March 2020 Prednidale 5 mg Tablets - Product defect recall alert 119072 vet level This recall is for a single batch of the product due to microbial contamination.
24 January 2020 Clavubactin 50/12.5mg, 250/62.5mg, 500/125mg 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 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.
29 August 2019 Isathal 10 mg/g eye drops, suspension for dogs, cats and rabbits A72346 vet level 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 vet level Particulates found in identified batches of product during routine stability testing program.
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.
15 May 2019 Tylan 200mg/ml Solution for Injection C967336A vet level Failed periodic revalidation (media fill test) that may affect the level of sterility assurance of certain products.

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 11 May 2020 + show all updates
  1. Added Foston 20% w/v Solution for Injection - Product defect recall alert

  2. Updated table of recalled products

  3. Updated table of recalled products

  4. Update to the table of recalled products - Clavubactin

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

  6. List of recalled products updated

  7. Updated List of recalled products

  8. Recalled products table updated

  9. Updated list of recalled products

  10. List of recalled products updated

  11. Updated Batch Recall table

  12. Updated Batch Recall table

  13. Updated Batch Recall table.

  14. Updated Batch Recall table

  15. Updated Product Defect Report form

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

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

  18. Batch Recall Table updated

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

  20. Batch Recall table updated

  21. Updated table

  22. Updated recalled product list

  23. Updatded recalled products list

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

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

  26. Product recall list updated

  27. Updated list of recalled products

  28. Updated Recall2 Form

  29. Updated Product defect report form added

  30. Table updated with the latest information

  31. Batch recall table has been updated.

  32. Product recall list updated

  33. First published.