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|
|28 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.|
|19 April 2017||Deosect 5% w/v Concentrate for Cutaneous Spray Solution||E16140, E16178, E16162||Aluminium foil seal appears to be defective resulting in slight leakage of the product during storage.|
|10 April 2017||Cefshot DC 250mg Intramammary Suspension for Cattle||ABE031A, ALS018A||Zoetis UK Ltd has identified that there is a small possibility that some syringes from the batches listed, have not been correctly sterilised.|
|07 February 2017||Propofol Emulsion for Injection 1.0% w/v||All products||An issue of coring has been reported, where the shearing off of a portion of the 20mm bromobutyl bung occurs as the vial is pierced to withdraw the product. This may result in particles from the bung entering the product. It may also result in the bung not resealing fully after use.|
|24 January 2017||Combinex Oral Suspension||C608040, C608744, C608747, C614045||When the product is used in conjunction with a product applicator gun, the applicator gun fails to operate, causing no product to pass through the gun and be administered to the animal.|
|13 December 2016||Loxicom 1.5mg/ml Oral Suspension for Dogs||6231-90D||The 1ml syringe within the pack of Loxicom Oral Suspension 1.5mg/ml for dogs has Lbs printed as the unit of measure instead of kg.|
|30 November 2016||Hipnoton 10 mg/ml Solution for injection for horses and cattle||DTH004, DTH006||Partial and total lack of efficacy for batches.|
|31 October 2016||Armitage Pet Care Flea and Tick Drops for Dogs 702 mg Spot-on Solution||All products||Dog product incorrectly packaged for cats.|
|28 October 2016||Framomycin 150 mg/ml solution for injection||G1211-02, G3823-02||Two batches have been placed on the market with an incorrect expiry date. Affected batches have a 3 year expiry date printed on the label. The SPC states 2 year shelf life.|
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 Analysis of reports received by the VMD in 2016-17 (PDF, 252KB, 7 pages) .
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: 13 October 2017
- Added link to analysis of reports received by the VMD in 2016-17
- Batch Recall table updated
- Updated table
- Updated recalled product list
- Updatded recalled products list
- Product Defect/Batch Recall Report Template (Recall 2) with the latest version
- Propofol Emulsion for Injection 1.0% w/v added to the recall table
- Product recall list updated
- Updated list of recalled products
- Updated Recall2 Form
- Updated Product defect report form added
- Table updated with the latest information
- Batch recall table has been updated.
- Product recall list updated
- First published.