FDA recall D-1161-2022

Product

Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-163-90 UPC 3 72789 16390 1

Reason for recall

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2022-06-06

Report date

2022-07-06

Termination date

2024-06-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Oklahoma City, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1161-2022