Multi event Drug Recall Enforcement Report Class II voluntary initiated by PD-Rx Pharmaceuticals, Inc., originally initiated on 10-06-2020 for the 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 The product was recalled due to cgmp deviations: detection of n-nitrosodimethylamine (ndma) impurity above the acceptable intake level (per manufacturer). The product was distributed in Ak, Az, Ca, Co, Fl, Ga, Id, Il, In, Ky, Mn, Nc, Ny, Ok, Or, Wi and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0060-2021 | 10-06-2020 | 11-11-2020 | Class II | 125 bottles | 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 | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) | Terminated |
| D-0059-2021 | 10-06-2020 | 11-11-2020 | Class II | 1683 bottles | 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 bottles, Rx only, Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 43063-902 | Metformin Hydrochloride Extended Release | Metformin Hydrochloride | Tablet, Extended Release | Oral | Pd-rx Pharmaceuticals, Inc. | Human Prescription Drug |
| 72789-009 | Metformin Hydrochloride Extended Release | Metformin Hydrochloride | Tablet, Extended Release | Oral | Pd-rx Pharmaceuticals, Inc. | Human Prescription Drug |
