MetFORMIN HCL ER USP 500 mg recalled over manufacturing violations

Recall date

June 5, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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:…

Recall number

D-1307-2020

FDA classification

Class II

Brand / firm

PD-Rx Pharmaceuticals, Inc.

Sold / distributed

United States

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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