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).
Complete the email@example.com send it to
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|
|29 August 2019||Isathal 10mg/g eye drops suspension for dogs, cats and rabbits||A72346||Out of specification result for particle size being found in routine stability testing.|
|21 June 2019||Alfaxan & Alfaxan Multidose 10mg/ml Solution for Injection||55523 48317 62816||Particulates found in identified batches of product during routine stability testing program.|
|17 May 2019||Norfenicol 300mg/ml Solution for Injection||9054-91B||Failed periodic revalidation (media fill test) that may affect the level of sterility assurance of certain products.|
|15 May 2019||Tylan 200mg/ml Solution for Injection||C967336A||Failed periodic revalidation (media fill test) that may affect the level of sterility assurance of certain products.|
|28 March 2019||Anaestamine 100mg/ml injection||All batches||Particles found in the vials of the product.|
|17 January 2019||Equimax Oral Gel for Horses Yardpacks||80126 80931||Packs of 48 syringes each containing 7.49 g of product are being recalled with immediate effect, as they do not contain English language package leaflets and the immediate packaging (sticker on dosing syringe) is not in English.|
|30 November 2018||Carprieve Small Animal Injection||8254-90G||Sterility not assured.|
|20 July 2018||Willcain Solution for Injection||92927 94340 94341 106023 106024 106025||Low active substance assay results during long term stability trial|
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
Further information on how VMD handles product defect reports can be found in.
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.