Guidance

Report a product defect: veterinary medicine

How a marketing authorisation holder should 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, 38.6 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
Nerfasin 20mg/ml Solution for Injection for Cattle, Horses, Dogs and Cats - Product defect recall alert 09/12/2021 19A242 19B191 19F221 19J038 19J214 Vet Level A small number of particles have been observed in the retain samples of five (5) batches of Nerfasin Solution for injection 20mg/ml xylazine.
Clindacutin Ointment 10 mg/g for dogs 15/11/2021 BC (21H258) BB (21H244) Wholesaler Level The product has been manufactured released according to specifications of the Dutch marketing authorisation which is not approved in this country.
Revozyn RTU 400 mg/ml Suspension for Injection for Cattlet 10/11/2021 20K091 Vet Level Confirmed out of specification particle size distribution (the percentage of particles greater that 50 µm exceeds the specification) and out of specification redispersion time.
Lydaxx 100 mg/ml solution for injection for cattle, pigs and sheep 17 August 2021 0C3829 Vet Level Vetoquinol have identified that there is a potential for the sterility/stability of the product to be compromised due to a crimping problem of the aluminium cap.
Ketofen 10% Solution for Injection 16 August 2021 108AB 113H Vet Level During the visual inspection it has been confirmed that there is a possibility of particulate contamination which is not acceptable for an intravenous use preparation.
Salmovac 440 15 June 2021 3000520B Vet Level Following testing Ceva Animal Health Ltd have confirmed that Batch No. 3000520B with an Expiry date of 11 December 2021 has live bacterial count values (potency) below the authorised specification and therefore there is potential for a lack of efficacy.
Prid Delta 1.55 g Vaginal Delivery System for Cattle 27 May 2021 76B11 76D11 77A11 77E11 79F11 81I11 82D11 83A11 83B11 84B11 84D11 89B11 89D11 Wholesaler Level When folding the device to insert into the applicator, the device can fold badly making it impossible to insert it or the internal skeleton can break. Could also lead to a lack of retention of device due to incorrect folding when inserted.
Otodex Skin Cream 3 February 2021 E001 E002 Vet Level This recall is initiated as the lidocaine content is marginally out of specification.
Carprieve 5% w/v Small Animal Solution for Injection 19 January 2021 0265-90 0302-90 0246-90 0112-90 0295-90 9053-91 9103-91 Vet Level This recall is initiated as a precautionary measure due to higher than usual impurities.

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.

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 15 December 2021 + show all updates
  1. Update to table of recalled products

  2. Update table of recalled products

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

  4. Salmovac 440 added to list of recalled products

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

  6. Updated to include January 2021 notices

  7. Table of recalled products updated

  8. Updated table of recalled products

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

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

  11. Updated table of recalled products

  12. Updated table of recalled products

  13. Update to the table of recalled products - Clavubactin

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

  15. List of recalled products updated

  16. Updated List of recalled products

  17. Recalled products table updated

  18. Updated list of recalled products

  19. List of recalled products updated

  20. Updated Batch Recall table

  21. Updated Batch Recall table

  22. Updated Batch Recall table.

  23. Updated Batch Recall table

  24. Updated Product Defect Report form

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

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

  27. Batch Recall Table updated

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

  29. Batch Recall table updated

  30. Updated table

  31. Updated recalled product list

  32. Updatded recalled products list

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

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

  35. Product recall list updated

  36. Updated list of recalled products

  37. Updated Recall2 Form

  38. Updated Product defect report form added

  39. Table updated with the latest information

  40. Batch recall table has been updated.

  41. Product recall list updated

  42. First published.