PD-Rx Pharmaceuticals, Inc. recalls metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: 4

Recalled June 24, 2020 · FDA recall D-1307-2020 · PD-Rx Pharmaceuticals

Hazard

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level · FDA Class II

Units

3703 bottles

Sold at

United States

Description

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Product

metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: 43063-428-90); d) 120 tablets (NDC: 43063-428-98); e) 180 tablets (NDC: 43063-428-93); f) 500 tablets (NDC: 53746-0178-05), Rx only, PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127

Manufacturer(s)

PD-Rx Pharmaceuticals, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →