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

FDA recall notice · announced November 11, 2020 · Pd-rx Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Notes

Distribution: AK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NC, NY, OK, OR, WI
Lot/code information: Lots: a) A20A97, B20D25 Exp. 04/30/21, B20D69, C20B95, C20D60, E20A50 Exp. 07/31/21, E20D37, E20D73 Exp. 03/31/22, J19F04 Exp. 01/31/21; b) C20C15 Exp. 07/31/21, F20A14 Exp. 03/31/22, L19C15 Exp. 04/30/21
Quantity: 125 bottles
Status: Terminated
Products in this recall event:
- 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 Pharmaceuti (D-0059-2021)
- 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 (D-0060-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.