Table 4.

Summary of seizures, recalls and case reports of medical products for diabetes management

Study	Report type	Location	API	Quality category and findings
Singh et al 107	Case report	South Korea and UK	Insulin (oral)	Substandard: Oral insulin used in clinical trial was adulterated with glibenclamide.
US FDA108	Recall	USA	Glibenclamide	Substandard: 45 lots of medicines containing glibenclamide were contaminated by fungus.
SEARPharm Forum Secretariat109	Seizure	India	Glibenclamide	Falsified glibenclamide was seized.
SecuringIndustry20	Seizure	China	Glibenclamide	Falsified: 9400 bottles seized. High glibenclamide content killed two people.
AboutLawsuits.com110	Recall	USA	Metformin	Substandard: 52 lots were contaminated with chemical substances.
Moreno Exebio et al 111	Seizure	Peru	Unspecified	Falsified: 4 samples found.
US FDA112	Seizure	USA	Metformin/rosiglitazone	Substandard: Coformulated tablets found not to meet the FDA standard formulation mix resulting in higher or lower API content. Manufacturer was also accused of product mix-up, causing tablets with different strength or type to be put in the wrong bottles.
Vanguard113	Seizure	Nigeria	Metformin	Falsified: 70 cartons found.
Taylor114	Seizure	Multinational	Glimepiride and rosiglitazone, other antidiabetic medicine (unspecified)	Falsified: International operation to address ‘online sales of illicit medicines’ (Operation Pangea). Including inspections and seizures of falsified medicines. Number of antidiabetic medicines not specified.
Woodcock115	Case report	USA	Insulin	Suspected degraded: Patient used resold stolen insulin, resulting in ‘poor blood glucose control, likely as a result of it (insulin) not being stored properly’.
Administracion Nacional de Medicamentos, Allmentos y Tecnologia66	Recall	Argentina	Insulin	Falsified: 2 lots of insulin; detected through the national medicine tracking system.
Dominican Today116	Seizure	Dominican Republic	Unspecified	Falsified: 1 person arrested. ‘Among the drugs seized there are painkillers, antibiotics and others used to combat hypertension and diabetes mellitus.’
Medicines and Healthcare Products Regulatory Agency117	Seizure	UK and 114 other countries	Unknown	Falsified: A part of Operation Pangea; 156 arrests made worldwide. ‘Types of medicines seized include […] diabetes […].’
Market118	Recall	India	Glimepiride	Substandard: Tablets failed dissolution test.
FDA Philippines119	Recall	Philippines	Lixisenatide	Substandard: 3 batches found.
Vanhee et al 65	Seizure	Belgium	Insulin	SorF: 20 samples of ‘suspected illegal insulins’ seized by the Belgium Federal Agency for Medicinal and Health Products, porcine insulin with degradation product detected.

API, active pharmaceutical ingredient; FDA, Food and Drug Administration; SorF, substandard or falsified.