Classification of urgency

Classification of urgency for a batch recall of quality defects observed in veterinary medicinal products:

Class 1 defects are potentially life-threatening


  • wrong product (label and content differ from each other)
  • right product but wrong content, with serious medical consequences
  • microbial contamination of a sterile injection or ophthalmic product
  • chemical contamination with serious medical consequences
  • exchange of some deviating products (e.g. red between yellow tablets, other packaging) involving more than 1 package
  • wrong active substance in a combination preparation, with serious medical consequences.

Class 2 defects could cause illness or improper treatment but are not class 1 defects


  • incorrect label due to incorrect or missing text or images
  • missing or incorrect information (in folder or attachment)
  • microbial contamination of a non-injection preparation or non-ophthalmic product with medical consequences
  • chemical or physical contamination (significant impurities, cross-contamination, particles)
  • deviating products mixed together in containers
  • not according to the specifications (determination of content, stability, volume/weight)
  • unsafe closure with serious medical consequences (cytotoxic, child-safe packaging, fast-acting products).

Class 3 defects may not pose a significant danger to (animal) health, but the batch may be retrieved for other reasons


  • defective/incorrect packaging, e.g. wrong or missing batch number or expiry date
  • defective/incorrect sealing
  • contamination, e.g. microbial spoilage, dirt or sediment, matter particles.