Summary of seizures, recalls and case reports of medical products for diabetes management
| Study | Report type | Location | API | Quality category and findings |
| Singh et al107 | 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 al111 | 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 al65 | 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.