PD-Rx Pharmaceuticals, Inc. recalls metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 tablets NDC: 43
Recalled November 11, 2020 · FDA recall D-0060-2021 · PD-Rx Pharmaceuticals
Hazard
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) · FDA Class II
Units
125 bottles
Sold at
AK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NC, NY, OK, OR, WI
Description
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
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
Manufacturer(s)
PD-Rx Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →