FDA recall D-0885-2022

Product

Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00

Reason for recall

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

Distribution

Recalled product was distributed to Florida.

Key facts

Status

Terminated

Initiation date

2022-05-04

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-0885-2022