Table 2 Defects by categories and subcategories

I

Contamination (n = 59,36.2)

Colour variations, impurities, outside standards (n = 49)

Lack of sterility (n = 7)

Microbiological contamination (n = 3)

II

Stability defects (n = 41, 25.2)

Unspecified stability failure (n = 33)

Failure in dissolution test (n = 8)

III

Active pharmaceutical ingredient (API) defects (n = 26, 15.9)

API out of specification (either more or less) (n = 26)

IV

Variation in physical properties such as weight and volume (n = 4, 2.4)

Weight variation (n = 3)

Volume variation in single dose parenteral preparation (n = 1)

V

Packaging and labelling defects (n = 27, 16.6)

Failure in container closure system functionality (n = 6)

Packaging in a wrong carton (n = 1)

Manufacturer's information missing (n = 4)

Contain a lesser number of tablets than stated (n = 1)

Failure to comply with the description as per the manufacturer’s specifications (n = 7)

Labelling errors (n = 8)

VI

Adverse events reported (n = 1, 0.6)

A cluster of adverse drug reaction (ADR) events reported (n = 1)

VII

Unclassified (n = 5, 3.0)

Data not adequate to assess (n = 5)