GovWire

Guidance: Report a product defect: veterinary medicine

Veterinary Medicines Directorate

June 16
08:56 2023

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
Beaphar Dog Flea Shampoo and Pets with Wilko Insecticidal Dog shampoo 15/06/2023 155552 375067 3000135 478258 End User Potential quality issue
Versifel FeLV Suspension for Injection for Cats 13/06/2023 665276 Vet Level An atypically high reporting of the adverse events already defined within the Summary of Product Characteristics (SPC)
Johnsons Small Animal Insecticidal Shampoo 125ml and Dog Flea Shampoo 200ml 26/05/2023 All batches End User Potential quality issue
Clavudale 40 mg/10 mg tablets for cats and dogs 28/04/2023 All in-date batches Vet Level Stability failure of the product, attributed to the suitability of the primary closure

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 16 June 2023 +show all updates
  1. List of batch recalls updated

  2. Product list updated: Johnsons Small Animal Insecticidal Shampoo 125ml and Dog Flea Shampoo 200ml Product defect recall added

  3. Product defect recall added for Clavudale 40 mg/10 mg tablets for cats and dogs

  4. Batch recall for Prednidale 5 mg Tablets added

  5. Product added: Flukiver 5% w/v Oral Suspension - product defect batch recall alert

  6. Product defect batch recall alert Baytril Piglet Doser 0.5% Oral Solution added.

  7. Product recall list for last 12 months updated

  8. Update to table of recalled products

  9. Update table of recalled products

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

  11. Salmovac 440 added to list of recalled products

  12. Product defect recall alert added for Prid Delta 1.55 g

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