Veterinary Medicines Directorate
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 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 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 |
| Visqodip 0.535% w/v Ready to Use Teat Dip Solution | 13/04/2023 | 30718, 30234, 24915, 24615, 24306, 23943, 23541, 23127, 23010, 22723, 22207, 21605, 20633, 20409, 20318, 20112, 14619, 14148, 13552, 13001, 13110, 13002, 12253, 11716 | End User | Concerns regarding the stability of Visqodip when over 12 months old |
| Prednidale 5 mg Tablets - Product defect batch recall alert | 07/03/2023 | 136037 | Vet Level | Potential mould contamination after opening of the primary container |
| Flukiver 5% w/v Oral Suspension - product defect batch recall alert | 10/02/2023 | 22FQ211 | Wholesaler Level | The lot number on this batch is incorrect |
| Baytril Piglet Doser 0.5% Oral Solution | 02/02/2023 | KV045EX | Wholesaler Level | The expiry date on this batch is incorrect |
| Anesketin 100 mg/ml solution for injection for dogs, cats and horses | 06/01/2023 | 140461 | Vet Level | A compromised closure of the vials |
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.
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.
Contact
Alternatively phone the Inspections team via the switchboard on, 01932 336911.
Last updated 2 May 2023 +show all updates
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Product defect recall added for Clavudale 40 mg/10 mg tablets for cats and dogs
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Batch recall for Prednidale 5 mg Tablets added
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Product added: Flukiver 5% w/v Oral Suspension - product defect batch recall alert
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Product defect batch recall alert Baytril Piglet Doser 0.5% Oral Solution added.
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Product recall list for last 12 months updated
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Update to table of recalled products
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Update table of recalled products
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Updated table of recalled products: Lydaxx 100 mg/ml solution for injection for cattle, pigs and sheep Ketofen 10% Solution for Injection
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Salmovac 440 added to list of recalled products