FDA recall D-0886-2022

RemedyRepack Inc. · Class II · drug

Product

Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09

Reason for recall

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

Distribution

Product was distributed to FL, SC and VA

Key facts

Status: Terminated
Initiation date: 2022-05-02
Report date: 2022-06-01
Termination date: 2022-09-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Indiana, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0886-2022