Product: metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 tablets NDC: 43063-902-30; b) 60 tablets NDC: 43063-902-60
Reason for recall: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Recall initiated: 20201006
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated