Guidance

Report a product defect: veterinary medicine

How a marketing authorisation holder should report a defect with a veterinary medicine.

From:
Veterinary Medicines Directorate
Published
17 November 2014
Last updated
25 September 2024 — See all updates

Reporting a product defect

Only authorised veterinary medicines that are of suitable quality, safety and efficacy are permitted on the market. To ensure protection of animal and public health, we assess information about potentially defective products reported to us.

We receive reports by Marketing Authorisation Holders (MAHs) or by another National Competent Authority (NCA), via a Rapid Alert Notification (RAN) or a Good Manufacturing Practice statement of non-compliance.

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 (ODT, 38.6 KB) and send it to [email protected].

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, for example wholesaler level, veterinary practice level.

All other reporters should contact the marketing authorisation holder.

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
Prednicare 1 mg Tablets 25/09/24 24B01 Wholesalers/distributors, veterinarians and end-users Presence of 5 mg tablets
Milprazon Chewable 12.5 mg/125 mg Film-coated Tablets for Dogs Weighing at Least 5 kg - recall 09/08/2024 H15298 Wholesaler Microbiological non-compliance of this batch.
Ronidazole Capsules 02/08/2024 SCP2MA365, SCP2MA732, SCP2MB491, SCP2MB604, SCP2N0843, SCP2N1963, SCP2N1845, SCP2N1844, SCP201964, SCP2N2114, SCP2N3214 Veterinarian This is due to the quality of the product not being guaranteed.
Kexxtone 32.4g Continuous-Release Intraruminal Device for Cattle 30/07/2024 All in-date batches Veterinarian / pharmacy level A quality defect has resulted in cases where cattle regurgitated the device whilst it contained monensin tablets
Aquacare Swimbladder Treatment 29/07/2024 24103 & 25024 Wholesalers, retailers and end users The label artwork is referencing the wrong data source regarding re-dosing.
Fleasolve 134 mg Spot-on Solution for Medium Dogs 05/07/2024 0552023 Wholesaler Low Fipronil content
Johnson’s 4Fleas Tablets for Cats and Kittens 14/06/2024 E154176, 6-tablet packs End User Some units intended for cats packed in cartons of 4Fleas Tablets for Dogs (D085) Vm 00879/4062. These will contain the lower strength 11.4 mg tablets for cats with a possibility the product will be ineffective for dogs
Purevax® RCP and Eurican Herpes products 26/03/2024 F36880 F45117 F36877 F47461 F48040 Vet Level Potential presence of microcracks at the neck of some vials.
Anesketin 100 mg/ml 5ml Solution for Injection 13/03/2024 144611, 149131, 150269 Vet Level Potential leakage from the vials due to a discrepancy in processing settings
NARKETAN-10 100mg/ml Solution for Injection 21/02/2024 03786K Vet Level Potential cross-contamination which could impact the product efficacy
Listed King British Medicines 21/02/2024 300507001, 300338601, 300336001, 300491501, 414439, 414440 Retailer Some batches have been found to have a lower quantity of Malachite Green than specified, which may affect efficacy.
Finadyne 50 mg/ml Solution for Injection 21/11/2023 3044, 2030 Vet Level Presence of precipitate in the vials
Betamox 150 mg/ml Suspension for Injection 06/11/2023 3113-01A Vet Level Difficulties resuspending the product within a reasonable timeframe

What issues are classed as a product defect

These could include:

  • incorrect labelling, such as product strength, name of ingredients
  • misinformation or lack of information on the packaging or leaflets
  • incorrect manufacture, such as strength of the ingredients or an issue with the container
  • contamination of any kind
  • stability, such as expiry
  • counterfeit or deliberately tampered with product

A suspected defective product is one which:

  • proves to be harmful under normal conditions of use
  • has a composition that’s not as declared
  • has not had the controls on the finished product or during the manufacturing processes or other requirement of the manufacturing authorisation fulfilled

In cases of serious risk to animal or public health, we may instruct MAHs to suspend further supply of a product and/or to recall one or more defective batches from the market.

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.

Procedure for submitting product defect reports

MAHs should submit details of suspected defective reports to us on the  Product defect report form (ODT, 38.6 KB). The form requires details of:

  • The product name and its marketing authorisation (MA) number
  • The name of the MAH or distributor
  • The details of the manufacturing site(s) including the batch certification/release/importation sites
  • The batch number and expiry date of the product
  • The nature of the defect
  • Distribution details
  • The action taken or being taken by the MAH

Send the completed form to [email protected].

The product defect report will be logged and circulated to our Assessment Group comprising Quality, Safety & Efficacy assessors, GMP inspectors, pharmacovigilance vets and other experts for their comments.

The Assessment Group’s comments and requests for additional information are communicated to the MAH.

Correspondence will continue until we are satisfied that the MAH has effectively dealt with the product defect. This may include a product or batch recall, submission of a variation or even expiry of a product’s authorisation.

Classification of Product Defects

Product defects are classified using the following high level terms (HLTs):

High Level Term (HLT) Includes (Secondary details)
OOS Product is Out Of Specification (OOS) including: dissolution test results, ongoing stability (OGS), deviation from MA
Contamination Microbial cross-contamination, Chemical cross-contamination, Physical cross-contamination, Lack of sterility, Suspected transmission of an infectious agent via product
Packaging Defective package including blister packaging, closure or seal issue, packaging quantity issue, change not in accordance with MA, coring (crumbling/breakage of the rubber/other stopper when broached)
Labelling Product information literature issues including incorrect or missing information on the label of the immediate or outer packaging, package insert or leaflet
API Active Pharmaceutical Ingredient (API; also referred to as active substance) doesn’t meet required specification, including those notified via Statements of Non-Compliance
Other Any other defect, such as, counterfeit/fraudulent product, product not manufactured in accordance with Good Manufacturing Practice (GMP). Pharmacovigilance (PhV) issues including: adverse event, adverse reaction, suspected lack of expected efficacy. Physical issues including: product coating, product deposit, product dosage form, product gel formation

Product Recalls

Where a suspected defective product is considered to pose a serious risk to animal or public health we will normally instruct the MAH to withdraw the affected product from the market, that is, to initiate a product recall. The recall level will depend on the seriousness of the risk. Defects are classified Class 1 to 3 as below:

  • Class 1 (Critical): the defect presents a life threatening or serious risk to health
  • Class 2 (Major): the defect may cause mistreatment or harm to the animal but it is not critical
  • Class 3 (Minor): the defect is unlikely to cause harm to the patient and typically arises from non-compliance with the MA or the product’s specification

Class 1 defects will normally result in a product recall to the end-user, such as to farmer or pet owner.

Class 2 will normally result in a recall to retailer level, such as veterinary surgeon, pharmacist or suitably qualified person (SQP).

Class 3 defects may result in a recall to wholesale dealer although in most cases no recall is considered necessary.

For Class 1 and 2 recalls we will also issue a rapid alert notification (RAN) in accordance with the procedure described in the EMA’s Compilation of Community Procedures on Inspections and Exchange of Information.

In the case of Class 1 recalls, we send a RAN to other national competent authorities including EEA member States, PIC/S, EDQM, WHO, FDA and MRA partners, irrespective of whether the product/batch was exported to that country.

For Class 2 recalls, we send a RAN only to those national competent authorities where we know the batch has been distributed. We generally do not send a RAN for Class 3 recalls.

In some cases MAHs will themselves propose a product recall but in such circumstances the recall and the level must still be authorised by us.

All product recalls are published on GOV.UK and a 12-month rolling list is published on this page.

Contact

By email: [email protected]

Alternatively, submit a call-back request for the Inspections team via [email protected].

Updates to this page

Published 17 November 2014
Last updated 25 September 2024 + show all updates

  1. Added Prednicare 1mg tablets.

  2. Milprazon Chewable 12.5 mg/125 mg Film-coated Tablets for Dogs Weighing at Least 5 kg product defect recall added.

  3. Ronidazole Capsules - Product defect recall alert has been added to the List of recalled products table

  4. Updated table to include recall notices for Kexxtone 32.4g Continuous-Release Intraruminal Device for Cattle and Aquacare Swimbladder Treatment.

  5. Added recall for Fleasolve 134 mg Spot-on Solution for Medium Dogs

  6. Purevax® RCP FeLV lyophilisate and solvent for suspension for injection, Purevax® RCP lyophilisate solvent for suspension for injection, Eurican Herpes 205 Powder and Solvent for Emulsion for Injection added to List of recalled products table

  7. Anesketin 100 mg/ml 5ml Solution for Injection product defect recall added

  8. Narketan-10 and listed King British Medicines product recall notices added.

  9. Guidance reviewed and updated to include addition process information.

  10. List of batch recalls updated

  11. Product list updated: Johnson’s Small Animal Insecticidal Shampoo 125ml and Dog Flea Shampoo 200ml Product defect recall added

  12. Product defect recall added for Clavudale 40 mg/10 mg tablets for cats and dogs

  13. Batch recall for Prednidale 5 mg Tablets added

  14. Product added: Flukiver 5% w/v Oral Suspension - product defect batch recall alert

  15. Product defect batch recall alert Baytril Piglet Doser 0.5% Oral Solution added.

  16. Product recall list for last 12 months updated

  17. Update to table of recalled products

  18. Update table of recalled products

  19. Updated table of recalled products: Lydaxx 100 mg/ml solution for injection for cattle, pigs and sheep Ketofen 10% Solution for Injection

  20. Salmovac 440 added to list of recalled products

  21. Product defect recall alert added for Prid Delta 1.55 g Vaginal Delivery System for Cattle.

  22. Updated to include January 2021 notices

  23. Table of recalled products updated

  24. Updated table of recalled products

  25. Added Johnson’s 4Fleas 80mg Spot-on Solution for Cats to table of recalled products

  26. Added Foston 20% w/v Solution for Injection - Product defect recall alert

  27. Updated table of recalled products

  28. Updated table of recalled products

  29. Update to the table of recalled products - Clavubactin

  30. Recall notification for Isathal 10mg/g eye drops added

  31. List of recalled products updated

  32. Updated List of recalled products

  33. Recalled products table updated

  34. Updated list of recalled products

  35. List of recalled products updated

  36. Updated Batch Recall table

  37. Updated Batch Recall table

  38. Updated Batch Recall table.

  39. Updated Batch Recall table

  40. Updated Product Defect Report form

  41. Updated Analysis of Quality Product Defects received by the VMD in 2016-17 Report

  42. Oxytobel 10IU/ml added to the list of recalled products.

  43. Batch Recall Table updated

  44. Added link to analysis of reports received by the VMD in 2016-17

  45. Batch Recall table updated

  46. Updated table

  47. Updated recalled product list

  48. Updatded recalled products list

  49. Product Defect/Batch Recall Report Template (Recall 2) with the latest version

  50. Propofol Emulsion for Injection 1.0% w/v added to the recall table

  51. Product recall list updated

  52. Updated list of recalled products

  53. Updated Recall2 Form

  54. Updated Product defect report form added

  55. Table updated with the latest information

  56. Batch recall table has been updated.

  57. Product recall list updated

  58. First published.

Sign up for emails or print this page

Contents

Related content