Guidance: Report a product defect: veterinary medicine

Veterinary Medicines Directorate

February 21
17:25 2024

Reporting a product defect

Only authorised veterinary medicines that are of suitable quality, safety and efficacy are permitted on the market. To ensure protection of animal and public health, we assess information about potentially defective products reported to us.

We receive reports by Marketing Authorisation Holders (MAHs) or by another National Competent Authority (NCA), via a Rapid Alert Notification (RAN) or a Good Manufacturing Practice statement of non-compliance.

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

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
NARKETAN-10 100mg/ml Solution for Injection Product Defect Recall 21/02/2024 03786K Vet Level Potential cross-contamination which could impact the product efficacy.
Listed King British Medicines Product defect recall 21/02/2024 300507001, 300338601, 300336001, 300491501, 414439, 414440 Retailer Some batches have been found to have a lower quantity of Malachite Green than specified, which may affect efficacy.
Finadyne 50 mg/ml Solution for Injection - Product defect recall alert 21/11/2023 3044, 2030 Vet Level This recall is due to the presence of precipitate in the vials.
Betamox 150 mg/ml Suspension for Injection 06/11/2023 3113-01A Vet Level Difficulties resuspending the product within a reasonable timeframe.
Clavudale 400 mg/100 mg Tablets for Dogs 21/09/2023 R001 Vet, Wholesaler Stability failure
Beaphar Dog Flea Shampoo - Product defect recall alert 01/09/2023 974360, 37278701, 82876901, 727234 End User Potential quality issue
Buprevet 0.3 mg/ml Solution for Injection for Dogs and Cats Product recall 11/07/2023 0521403AA, 0521393AA, 0521398AA, 1120963AC, 0521404AA Vet Level A low active substance content was identified
Carprieve Tablets 50mg 03/07/2023 3123-60E Wholesaler Incorrect expiry date of 22/03/2022 printed on the blister packs
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 could 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

A suspected defective product is one which:

  • proves to be harmful under normal conditions of use
  • has a composition thats not as declared
  • has not had the controls on the finished product or during the manufacturing processes or other requirement of the manufacturing authorisation fulfilled

In cases of serious risk to animal or public health, we may instruct MAHs to suspend further supply of a product and/or to recall one or more defective batches from the market.

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.

Procedure for submitting product defect reports

MAHs should submit details of suspected defective reports to us on the Product defect report form (ODT, 38.6 KB). The form requires details of:

  • The product name and its marketing authorisation (MA) number
  • The name of theMAHor distributor
  • The details of the manufacturing site(s) including the batch certification/release/importation sites
  • The batch number and expiry date of the product<

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