On March 2, 2020, Valisure announced our detections high levels of N-Nitrosodimethylamine (NDMA) in specific lots of the drug metformin, a prescription medication used to control high blood sugar in adults and adolescents with type 2 diabetes.

Valisure’s analysis of 22 companies selling metformin and a total of 38 batches revealed 16 batches and 11 companies where NDMA levels were detected above the 96 nanograms (ng) acceptable daily intake limit. Several batches contained over 10 times the daily acceptable intake limit, and there was significant variability from batch to batch, even within a single company. These findings underscore the importance of batch-level chemical analysis and the necessity of effective quality surveillance of medications.

These results of NDMA in specific lots of the drug metformin resulted in recalls from five companies, including Amneal, Apotex, Lupin, Marksans (Time-Cap), Teva (Actavis), Granules.

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Click here for Valisure’s FDA Citizen Petition on Metformin

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Media Highlights:

• Bloomberg:  Carcinogen Found by Pharmacy in Popular U.S. Diabetes Drug
• Business Insider:  Online pharmacy Valisure says tests show carcinogen in diabetes drug metformin
• FDA News: Online Pharmacy Urges FDA to Pull Metformin Products With High NDMA Levels
• The People’s Pharmacy: Several Metformin Diabetes Drugs Contaminated with Nitrosamine
• The New York Times: Online Pharmacy Valisure Says Tests Show Carcinogen in Diabetes Drug Metformin
• MedPage Today:  More Carcinogen-Tainted Drugs
• NASDAQ: Valisure Challenges FDA’s Claims on Metformin’s Safety
• Pharmacist.com: Carcinogen found by pharmacy in popular U.S. diabetes drug
• Pharmacy Times:  High Levels of Carcinogen NDMA Found in Common Diabetes Medication
• Reuters: Online pharmacy Valisure says tests show carcinogen in diabetes drug metformin

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