Blood Pressure Drug Recalled

PD-Rx Pharmaceuticals Inc. is recalling 576 bottles of losartan potassium tablets because they contain trace amounts of the nitrosamine impurity NMBA, according to the May 5, 2021, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects losartan potassium, 50 mg, 60-tablet bottles (NDC 43063-854-60) and 90-tablet bottles (NDC 43063-854-90), from lots A19B99 (Exp. 11/30/19), B19A26 (Exp. 11/30/19), B19A69 (Exp. 11/30/19), E18F12 (Exp. 9/30/19), F18A12 (Exp. 9/30/19), F18F06 (Exp. 9/30/19), G18B43 (Exp. 9/30/19), G18C43 (Exp. 9/30/19), G18F75 (Exp. 9/30/19), H18D55 (Exp. 9/30/19), I18A11 (Exp. 9/30/19), I18E32 (Exp. 9/30/19), J18A90 (Exp. 9/30/19), J18D50 (Exp. 11/30/19), and L18D01 (Exp. 11/30/19).  

The recalled products were packaged by PD-Rx Pharmaceuticals, Oklahoma City, OK, and distributed in Alaska, Arizona, California, Colorado, Florida, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, Ohio, Oregon, Wisconsin, and Wyoming.

PD-Rx Pharmaceuticals voluntarily initiated the recall March 8, 2019. On April 26, 2021, the FDA designated the recalls Class II, communicating use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm. 

Losartan is a prescription drug used to treat high blood pressure.

—Jolynn Tumolo