Table 3.

Recalled substandard pharmaceutical products classified using the adopted EMA defect categorisation terminology.

High-level defect term	Number of products affected	Detail of the defect leading to recall	Number of products affected
Manufacturing laboratory control issue	37 (47.4%)	Out of specification assay result Failed water leak test & Bursting pressure Out of specification impurities result after 24 months Failed uniformity of weight test Stability failures under high temperature and humidity conditions. Non-compliant to dissolution test Low alcohol content Failed pH test Failed disintegration test Failed hung and roll, bursting volume, length test	9 4 1 4 2 1 13 1 1 1
Product contamination and sterility issues	23 (29.5%)	Lack of sterility Visible foreign particulates Identification of nitrosamine impurities Foreign matters on capsules Foreign materials in tablets Contained Mercury and a prescription only medication, Clobetasol Excessive amounts of Hydroxyquinone Detection of 4-chloro azido methyl tetrazole Failed bioburden test	1 3 7 1 1 1 1 7 1
Product label issue	1 (1.3%)	Wrong labelling for the route of administration	1
Product packaging issues	5 (6.4%)	Defective primary packaging	5
Product physical issue	12 (15.4%)	Tablet discoloration Solution discolouration Suspension caking Failed appearance test Crystallisation of syrup	4 2 1 4 1

EMA: European Medicines Agency.