Guidance

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).

Complete the Product defect report form (MS Word Document, 48.3KB) and send it to rapidalert@vmd.defra.gsi.gov.uk.

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
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.
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.

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, 244KB, 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.

Contact

rapidalert@vmd.defra.gsi.gov.uk

Alternatively phone the Inspections team via the switchboard on, 01932 336911.

Published 17 November 2014
Last updated 28 March 2018 + show all updates
  1. Updated Analysis of Quality Product Defects received by the VMD in 2016-17 Report
  2. Oxytobel 10IU/ml added to the list of recalled products.
  3. Batch Recall Table updated
  4. Added link to analysis of reports received by the VMD in 2016-17
  5. Batch Recall table updated
  6. Updated table
  7. Updated recalled product list
  8. Updatded recalled products list
  9. Product Defect/Batch Recall Report Template (Recall 2) with the latest version
  10. Propofol Emulsion for Injection 1.0% w/v added to the recall table
  11. Product recall list updated
  12. Updated list of recalled products
  13. Updated Recall2 Form
  14. Updated Product defect report form added
  15. Table updated with the latest information
  16. Batch recall table has been updated.
  17. Product recall list updated
  18. First published.