MISC - FDA Recall Class Flashcards
Wrong product (FDA recall class)
Class 1
Correct product but wrong strength, with serious consequences (FDA recall class)
Class 1
Microbial contamination of sterile products (FDA recall class)
Class 1
Chemical contamination with serious medical consequences (FDA recall class)
Class 1
Mix-up of some products with more than one container involved (FDA recall class)
Class 1
Wrong active ingredient in a multi-component product, with serious medical consequences (FDA recall class)
Class 1
Mislabeling (FDA recall class)
Class 2
Missing or incorrect information (FDA recall class)
Class 2
Microbial contamination of non-sterile products (FDA recall class)
Class 2
Chemical/physical contamination (FDA recall class)
Class 2
Mix-up of products in containers (FDA recall class)
Class 2
Non-compliance with specifications (FDA recall class)
Class 2
Faulty closure with serious medical consequences (FDA recall class)
Class 2
Faulty packaging (FDA recall class)
Class 3
Fault closure (FDA recall class)
Class 3
Contamination (FDA recall class)
Class 3
Product labelled with incorrect name or incorrect strength (FDA recall class)
Class 1
Counterfeit or deliberately tampered-with product (FDA recall class)
Class 1
Any labelling/leaflet misinformation (or lack of information) which represents significant hazard to a patient (FDA recall class)
Class 2
Non-compliance to specifications (e.g. active ingredient assay) (FDA recall class)
Class 2
Readily visible isolated packaging/closure faults (FDA recall class)
Class 3
