Table 4

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

StudyReport typeLocationAPIQuality category and findings
Singh et al107Case reportSouth Korea and UKInsulin (oral)Substandard: Oral insulin used in clinical trial was adulterated with glibenclamide.
US FDA108RecallUSAGlibenclamideSubstandard: 45 lots of medicines containing glibenclamide were contaminated by fungus.
SEARPharm Forum Secretariat109SeizureIndiaGlibenclamideFalsified glibenclamide was seized.
SecuringIndustry20SeizureChinaGlibenclamideFalsified: 9400 bottles seized. High glibenclamide content killed two people.
AboutLawsuits.com110RecallUSAMetforminSubstandard: 52 lots were contaminated with chemical substances.
Moreno Exebio et al111SeizurePeruUnspecifiedFalsified: 4 samples found.
US FDA112SeizureUSAMetformin/ rosiglitazoneSubstandard: 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.
Vanguard113SeizureNigeriaMetforminFalsified: 70 cartons found.
Taylor114SeizureMultinationalGlimepiride 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.
Woodcock115Case reportUSAInsulinSuspected 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 Tecnologia66RecallArgentinaInsulinFalsified: 2 lots of insulin; detected through the national medicine tracking system.
Dominican Today116SeizureDominican RepublicUnspecifiedFalsified: 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 Agency117SeizureUK and 114 other countriesUnknownFalsified: A part of Operation Pangea; 156 arrests made worldwide.
‘Types of medicines seized include […] diabetes […].’
Market118RecallIndiaGlimepirideSubstandard: Tablets failed dissolution test.
FDA Philippines119RecallPhilippinesLixisenatideSubstandard: 3 batches found.
Vanhee et al65SeizureBelgiumInsulinSorF: 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.