TableĀ 2

Substandard medicines

Defect typeNumber of medicinesPer centDefect detailsNumber of medicines
Contamination7427Impurities44
Lack of sterility assurance18
Microbial contamination12
Minor packaging defects7025Failure to update PIL with administration or safety warning40
Incorrect information/description of the dosage form, strength or dose of a medicine12
Missing or packing PIL with the wrong carton6
Others12
Delivery defects3312Fault with a device19
Leakage or loose seal9
Others5
Major packaging defects2810Missing or incorrect name ,strength, or active ingredient of a medicine on carton or box22
Packing a medicine in the wrong carton6
Stability defects238Unspecified stability failure15
Stability failure of the active ingredient or dissolution failure prior to expiry8
Defects in active ingredient83Active ingredient is out of specification (either more or less)6
Non-homogeneity of the active ingredient in the formulation2
Potency72Subpotent medicine (underlying causes of subpotency were not stated)7
Other defects3713GMP deficiencies at manufacturing site or improper storage of medicines during shipment23
Others14
Total280100280
  • GMP, good manufacturing practice; PIL, patient information leaflet.