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.