Veterinary Medicines Directorate
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 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 |
|---|---|---|---|---|
| Fleasolve 134 mg Spot-on Solution for Medium Dogs | 05/07/2024 | 0552023 | Wholesaler | The reason for the recall is due to low Fipronil content. |
| Johnsons 4Fleas Tablets for Cats and Kittens | 14/06/2024 | E154176, 6-tablet packs | End User | Some units intended for cats packed in cartons of 4Fleas Tablets for Dogs (D085) Vm 00879/4062. These will contain the lower strength 11.4 mg tablets for cats with a possibility the product will be ineffective for dogs. |
| Purevax RCP and Eurican Herpes products | 26/03/2024 | F36880 F45117 F36877 F47461 F48040 | Vet Level | Potential presence of microcracks at the neck of some vials. |
| Anesketin 100 mg/ml 5ml Solution for Injection | 13/03/2024 | 144611, 149131, 150269 | Vet Level | Potential leakage from the vials due to a discrepancy in processing settings. |
| 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 | 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 |
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.
Legal requirement
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. 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
- The nature of the defect
- Distribution details
- The action taken or being taken by theMAH
Send the completed form to