Reporting product or batch defects that could result in a recall

Any product or batch defect relating to a product sold in the UK should be reported to the VMD.

Details should be sent to Denise Burge d.burge@vmd.defra.gsi.gov.uk (01932 338427) using the Product Defect Report form (Microsoft Word format).

Where a defect is likely to result in a recall of a batch or product please contact the VMD for advice and where appropriate give details of the level of recall, e.g. wholesaler level, veterinary practice level.
 

What defects could necessitate a product or batch recall?

• Incorrect labelling, e.g. the strength of the product, the name of the active ingredient.

• Misinformation or lack of information in the product literature.

• Incorrect manufacture, e.g. the strength of the product ingredients, the product container.

• Contamination, e.g. chemical, microbial, physical.

• Stability, e.g. expiry.

• Counterfeit or deliberately tampered-with product.
   

Legal basis

Each 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 (MHRA Latest Drug Alerts)

This link takes you to the MHRA Safety Information page and includes current and historic alerts:

• Drug alerts on defective medicines. 

• Medical device alerts and their predecessors.

• Safety warnings and messages about medicines, including letters sent to health professionals.