Report a product defect: veterinary medicine

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	Notification Date	Batch No.	Level of Recall	Problem
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	26/03/2024	F36880 F45117 F36877 F47461 F48040	Vet Level	This recall is due to the 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	The reason for the recall is potential leakage from the vials due to a discrepancy in processing settings.
NARKETAN-10 100mg/ml Solution for Injection – Product Defect Recall	21/02/2024	03786K	Vet Level	Potential cross-contamination which could impact the product efficacy.
Listed King British Medicines – Product defect recall	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 - Product defect recall alert	21/11/2023	3044, 2030	Vet Level	This recall is due to the 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.
Clavudale 400 mg/100 mg Tablets for Dogs	21/09/2023	R001	Vet, Wholesaler	Stability failure
Beaphar Dog Flea Shampoo - Product defect recall alert	01/09/2023	974360, 37278701, 82876901, 727234	End User	Potential quality issue
Buprevet 0.3 mg/ml Solution for Injection for Dogs and Cats Product recall	11/07/2023	0521403AA, 0521393AA, 0521398AA, 1120963AC, 0521404AA	Vet Level	A low active substance content was identified
Carprieve Tablets 50mg	03/07/2023	3123-60E	Wholesaler	Incorrect expiry date of 22/03/2022 printed on the blister packs
Beaphar Dog Flea Shampoo and Pets with Wilko Insecticidal Dog shampoo	15/06/2023	155552, 375067, 3000135, 478258	End User	Potential quality issue
Versifel FeLV Suspension for Injection for Cats	13/06/2023	665276	Vet Level	An atypically high reporting of the adverse events already defined within the Summary of Product Characteristics (SPC)
Johnson’s Small Animal Insecticidal Shampoo 125ml and Dog Flea Shampoo 200ml	26/05/2023	All batches	End User	Potential quality issue
Clavudale 40 mg/10 mg tablets for cats and dogs	28/04/2023	All in-date batches	Vet Level	Stability failure of the product, attributed to the suitability of the primary closure

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.