FDA Citizen Petition #3: NDMA Carcinogen in Metformin

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.

Complete Valisure Citizen Petition Documents:

Media highlights:

FDA Citizen Petition #3: NDMA Carcinogen in Metformin

April 8, 2022

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.

Complete Valisure Citizen Petition Documents:

Media highlights:

FDA Citizen Petition #3: NDMA Carcinogen in Metformin

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.

Complete Valisure Citizen Petition Documents:

Media highlights:

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.

Complete Valisure Citizen Petition Documents:

Media highlights:

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