FDA recall D-0341-2021

Product

Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 60 Tablets NDC: 43063-854-60; b) 90 Tablets NDC: 43063-0854-90

Reason for recall

CGMP deviation: Product found to contain trace amounts of NMBA

Distribution

AK, AZ, CA, CO, FL, KY, MA, MI, MN, NC, OH, OR, WI, WY

Key facts

Status

Terminated

Initiation date

2019-03-08

Report date

2021-05-05

Termination date

2021-06-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Oklahoma City, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0341-2021