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 (MS Word Document, 49KB) and send it to rapidalert@vmd.defra.gsi.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
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
12 July 2018 Filavac VHD K C+V 060K80412C1A-UK1-2 060K80412A1C-UK1-2 Incorrect storage requirements during shipment.
12 July 2018 Trimax Plus 4 in 1 liquid for racing pigeons 170109 170322 171012 180214 Precipitation has occurred in some stored samples reducing active ingredient in solution to below minimum specified level before expiry date.
19 June 2018 Crovect 1.25% w/v Pour-on Solution for Sheep 20556 20723 20822 Possible presence of a defect in the pack, which may cause the caps to split.
07 June 2018 Stresnil 40 mg/ml Solution for Injection for Pigs PP1466 Inconsistencies in the cleaning process have led to low levels of a previous product being carried over into the Stresnil batch.

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, 244KB, 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.defra.gsi.gov.uk

Alternatively phone the Inspections team via the switchboard on, 01932 336911.

Published 17 November 2014
Last updated 21 May 2019 + show all updates
  1. Updated List of recalled products
  2. Recalled products table updated
  3. Updated list of recalled products
  4. List of recalled products updated
  5. Updated Batch Recall table
  6. Updated Batch Recall table
  7. Updated Batch Recall table.
  8. Updated Batch Recall table
  9. Updated Product Defect Report form
  10. Updated Analysis of Quality Product Defects received by the VMD in 2016-17 Report
  11. Oxytobel 10IU/ml added to the list of recalled products.
  12. Batch Recall Table updated
  13. Added link to analysis of reports received by the VMD in 2016-17
  14. Batch Recall table updated
  15. Updated table
  16. Updated recalled product list
  17. Updatded recalled products list
  18. Product Defect/Batch Recall Report Template (Recall 2) with the latest version
  19. Propofol Emulsion for Injection 1.0% w/v added to the recall table
  20. Product recall list updated
  21. Updated list of recalled products
  22. Updated Recall2 Form
  23. Updated Product defect report form added
  24. Table updated with the latest information
  25. Batch recall table has been updated.
  26. Product recall list updated
  27. First published.