June 03, 2020
The U.S. Food and Drug Administration is announcing today that agency laboratory testing has revealed levels of the nitrosamine impurity N-Nitrosodimethylamine (NDMA) above the agency’s acceptable intake limit in several lots of the extended-release (ER) formulation of metformin, a prescription drug used to control high blood sugar in patients with type 2 diabetes. The agency is in contact with five firms to recommend they voluntarily recall their products.
At this time, the elevated levels of NDMA have been found in some finished-dose tablets of the ER formulation but the FDA has not detected NDMA in samples of the metformin active pharmaceutical ingredient.(1)
We are able to compound metformin in different dosage forms including topical and Extended release forms. We only use USP Grade Metformin from FDA registered suppliers for compounding which dose not contain NDMA.
Link to FDA Press Release: Click Here
(1) Commissioner, O. of the. (n.d.). vFDA Alerts Patients and Health Care Professionals to Nitrosamine Impurity Findings in Certain Metformin Extended-Release Products. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-alerts-patients-and-health-care-professionals-nitrosamine-impurity-findings-certain-metformin
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