Report a product defect: veterinary medicine
For a marketing authorisation holder only; how to 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).
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, e.g. wholesaler level, veterinary practice level.
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.
|Notification Date||Product||Batch No.||Problem|
|11 October 2016||Genta-Equine 100mg/ml Solution for Injection for Horses||6054-81A||Product contamination and adverse events reported.|
|5 August 2016||Mipet Clavapet 50 mg Tablets for Dogs and Cats||5195-61A, 5195-60H, 5195-6OI||The affected tablets were displaying signs of discolouration which is indicative of possible degradation.|
|27 July 2016||IsoFlo 100% w/w Inhalation Vapour, Liquid & Isothesia 1000 mg/g Inhalation Vapour, Liquid||58006XN, 60003XN, 59005XN, 60006XN, 61001XN, 60016XN, 60017XN, 61018XN, 61015XN, 61016XN, 61017XN, 6062216, 6062225, 6062226, 6062217, 6063738, 6062335, 6063318||The screw thread present on the cap of a small number of bottles can be susceptible to over-tightening, resulting in the bottle not providing an airtight seal.|
|20 May 2016||Ivermectin 1% solution for injection (Molemec Super 500ml)||AF231/14||Potential risk for the product to be under the low specification (95%) before the expiry dates of batches on the market.|
|8 April 2016||Vetflurane 1000 mg/g Inhalation Vapour, Liquid||5NDL||Faulty container. Cannot re-seal once opened.|
What issues are classed as a product defect?
These would include:
- incorrect labelling (e.g. product strength, name of ingredients)
- misinformation or lack of information on the packaging or leaflets
- incorrect manufacture (e.g. strength of the ingredients or an issue with the container)
- contamination of any kind
- stability (e.g. expiry)
- counterfeit or deliberately tampered with product
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.
Alternatively phone the Inspections team via the switchboard on, 01932 336911.
Published: 17 November 2014
Updated: 8 December 2016
- Updated Product defect report form added
- Table updated with the latest information
- Batch recall table has been updated.
- Product recall list updated
- First published.