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.

Product Notification Date Batch No. Level of Recall Problem
Otodex Skin Cream - Product defect recall alert 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.
Gallifen 200 mg/ml Suspension, Pigfen 200 mg/ml Suspension 30 September 2020 19041748008 19091748023 18061747014 18091747020 19011747001 19031747019 Vet Level Fenbendazole content has been found lower than the agreed specification limit and sediment/caking layer is present on bottom of the bottle.
Carprieve 50 mg/ml Solution for Injection for Cattle 23 September 2020 9371-90 9372-90 9373-91 0105-90 vet level During stability monitoring analysis of Carprofen Injection for Cattle, a related substance (process impurity) was detected which exceeded the stability specification for an individual impurity (of 1.5%). The process impurity was isolated and the best estimate of identity indicated that the impurity is carprofen related.
Prednidale 5 mg Tablets 16 September 2020 119501 120633 vet level This recall is due to microbial contamination
Johnson’s 4Fleas 80mg Spot-on Solution for Cats 02 September 2020 KP0F3U7 wholesaler level This recall is of a single batch of the product due to a labelling error.
Foston 20% w/v Solution for Injection 16 April 2020 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.
Prednidale 5 mg Tablets 05 March 2020 119072 vet level This recall is for a single batch of the product due to microbial contamination.
Clavubactin 50/12.5mg, 250/62.5mg, 500/125mg 24 January 2020 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.

What issues are classed as a product defect

These 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 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 22 January 2021 + show all updates
  1. Updated to include January 2021 notices

  2. Table of recalled products updated

  3. Updated table of recalled products

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

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

  6. Updated table of recalled products

  7. Updated table of recalled products

  8. Update to the table of recalled products - Clavubactin

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

  10. List of recalled products updated

  11. Updated List of recalled products

  12. Recalled products table updated

  13. Updated list of recalled products

  14. List of recalled products updated

  15. Updated Batch Recall table

  16. Updated Batch Recall table

  17. Updated Batch Recall table.

  18. Updated Batch Recall table

  19. Updated Product Defect Report form

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

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

  22. Batch Recall Table updated

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

  24. Batch Recall table updated

  25. Updated table

  26. Updated recalled product list

  27. Updatded recalled products list

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

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

  30. Product recall list updated

  31. Updated list of recalled products

  32. Updated Recall2 Form

  33. Updated Product defect report form added

  34. Table updated with the latest information

  35. Batch recall table has been updated.

  36. Product recall list updated

  37. First published.