Product: Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534  NDC 72189-064-90
Reason for recall: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Recall initiated: 20201012
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated