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|
|19 June 2018||Crovect 1.25% w/v Pour-on Solution for Sheep||20556 20723 20822||Possible presence of a defect in the pack, which may cause the caps to split.|
|07 June 2018||Stresnil 40 mg/ml Solution for Injection for Pigs||PP1466||Inconsistencies in the cleaning process have led to low levels of a previous product being carried over into the Stresnil batch.|
|25 April 2018||Alvegesic vet. 10 mg/ml Solution for injection for Horses, Dogs and Cats||PO0545||Related to contamination during production.|
|09 March 2018||Oxytobel 10 IU/ml Solution for Injection||J2101-03||There is a potential for decreased levels of the preservative Chlorobutanol hemihydrate in the affected batch.|
|16 February 2018||Ornicure 150mg/g doxycycline powder for oral solution||16L16 741 16L19 742 16L15 739||Damage to 200g packages found during stability testing.|
|26 September 2017||Meloxaid 5mg/ml Solution for Injection||6094-93B 6094-94M||An OOS for pH was identified for the product during the sampling and analysis programme.|
|24 May 2017||Flypor 4% w/v Pour-on Solution||C681480||Some units in this batch have been reported to be leaking a small amount of product from around the cap due to the induction heat seals in some packs not being completely sealed to the bottle.|
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.