Product: metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-009-90); d) 180 tablets (NDC 72789-009-93); e) 100 tablets (NDC 49483-0623-01)  bottles, Rx only PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127
Reason for recall: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recall initiated: 20200605
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated