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).

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.

List of recalled products

Products recalled in the UK in the last 12 months.

Product	RecallNotification Date	Batch No.	Level of Recall	Problem
Revozyn RTU 400 mg/ml Suspension for Injection for Cattle - Recall alert - GOV.UK	25/03/25	24F042	Wholesaler	This recall is due to a stability failure of the product re-suspendability.
	Prednicare 1 mg Tablets	25/09/24	24B01	Wholesalers/Wholesalers/distributors, 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	09/08/2409/08/2024	H15298	Wholesaler	Microbiological non-compliance of this batch.
	Ronidazole Capsules	02/08/2402/08/2024	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	30/07/2430/07/2024	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	29/07/2429/07/2024	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	05/07/2405/07/2024	0552023	Wholesaler	Low Fipronil content
	Johnson’s 4Fleas Tablets for Cats and Kittens	14/06/2414/06/2024	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.

Legal requirement

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 rapidalert@vmd.gov.uk.

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: rapidalert@vmd.gov.uk

Alternatively, submit a call-back request for the Inspections team via postmaster@vmd.gov.uk.