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 |
|---|---|---|---|---|
| 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.
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 rapidalert@vmd.gov.uk.
The product defect report will be logged and circulated to our Assessment Group comprising Quality, Safety & Efficacy assessors, GMP inspectors, pharmacovigilance vets and other experts for their comments.
The Assessment Groups comments and requests for additional information are communicated to theMAH.
Correspondence will continue until we are satisfied that theMAHhas effectively dealt with the product defect. This may include a product or batch recall, submission of a variation or even expiry of a products authorisation.
Classification of Product Defects
Product defects are classified using the following high level terms (HLTs):