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.
|Product||Notification Date||Batch No.||Level of Recall||Problem|
|Otodex Skin Cream - Product defect recall alert||3 February 2021||E001 E002||Vet Level||This recall is initiated as the lidocaine content is marginally out of specification.|
|Carprieve 5% w/v Small Animal Solution for Injection||19 January 2021||0265-90 0302-90 0246-90 0112-90 0295-90 9053-91 9103-91||Vet Level||This recall is initiated as a precautionary measure due to higher than usual impurities.|
|Gallifen 200 mg/ml Suspension, Pigfen 200 mg/ml Suspension||30 September 2020||19041748008 19091748023 18061747014 18091747020 19011747001 19031747019||Vet Level||Fenbendazole content has been found lower than the agreed specification limit and sediment/caking layer is present on bottom of the bottle.|
|Carprieve 50 mg/ml Solution for Injection for Cattle||23 September 2020||9371-90 9372-90 9373-91 0105-90||vet level||During stability monitoring analysis of Carprofen Injection for Cattle, a related substance (process impurity) was detected which exceeded the stability specification for an individual impurity (of 1.5%). The process impurity was isolated and the best estimate of identity indicated that the impurity is carprofen related.|
|Prednidale 5 mg Tablets||16 September 2020||119501 120633||vet level||This recall is due to microbial contamination|
|Johnson’s 4Fleas 80mg Spot-on Solution for Cats||02 September 2020||KP0F3U7||wholesaler level||This recall is of a single batch of the product due to a labelling error.|
|Foston 20% w/v Solution for Injection||16 April 2020||A121A A122A A123A||wholesaler level||In the course of an internal review, it was noted that the available data for the product Foston 20% w/v Solution for Injection no longer meets the current EU regulations for food-producing species.|
|Prednidale 5 mg Tablets||05 March 2020||119072||vet level||This recall is for a single batch of the product due to microbial contamination.|
|Clavubactin 50/12.5mg, 250/62.5mg, 500/125mg||24 January 2020||19D82 18D11 18G32 19D83 17F46 17H35 18D13 19D88 17C80 17F47 17H38 18D17 18D18 18G34||vet level||During routine stability testing, the products mentioned do not fulfil the mandatory testing requirements at 24 months. This recall is because the efficacy of the product cannot be guaranteed after 12 months.|
What issues are classed as a product defect
- 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 the VMD handles product defect reports.
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.