Report a product defect: veterinary medicine
How a marketing authorisation holder should report a defect with a veterinary medicine.
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 |
|---|---|---|---|---|
| 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 |
| Product defect batch recall alert Baytril Piglet Doser 0.5% Oral Solution | 02/02/2023 | KV045EX | Wholesaler Level | The expiry date on this batch is incorrect |
| Product defect recall alert for Anesketin 100 mg/ml solution for injection for dogs, cats and horses | 06/01/2023 | 140461 | Vet Level | A compromised closure of the vials |
| Nerfasin 20 mg/ml Solution for Injection for Cattle, Horses, Dogs and Cats Product defect recall alert | 18/07/22 | All batches on the market | Vet Level | Particulate matter found in retained samples that were previously particle free |
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
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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
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Product defect recall alert added for Prid Delta 1.55 g Vaginal Delivery System for Cattle.
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Updated to include January 2021 notices
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Table of recalled products updated
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Updated table of recalled products
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Added Johnson’s 4Fleas 80mg Spot-on Solution for Cats to table of recalled products
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Added Foston 20% w/v Solution for Injection - Product defect recall alert
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Updated table of recalled products
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Updated table of recalled products
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Update to the table of recalled products - Clavubactin
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Recall notification for Isathal 10mg/g eye drops added
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List of recalled products updated
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Updated List of recalled products
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Recalled products table updated
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Updated list of recalled products
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List of recalled products updated
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Updated Batch Recall table
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Updated Batch Recall table
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Updated Batch Recall table.
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Updated Batch Recall table
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Updated Product Defect Report form
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Updated Analysis of Quality Product Defects received by the VMD in 2016-17 Report
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Oxytobel 10IU/ml added to the list of recalled products.
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Batch Recall Table updated
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Added link to analysis of reports received by the VMD in 2016-17
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Batch Recall table updated
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Updated table
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Updated recalled product list
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Updatded recalled products list
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Product Defect/Batch Recall Report Template (Recall 2) with the latest version
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Propofol Emulsion for Injection 1.0% w/v added to the recall table
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Product recall list updated
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Updated list of recalled products
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Updated Recall2 Form
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Updated Product defect report form added
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Table updated with the latest information
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Batch recall table has been updated.
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Product recall list updated
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First published.