FDA recall D-1164-2022

Product

Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC # 33342-052-44, Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

Reason for recall

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

Distribution

Product was distributed nationwide.

Key facts

Status

Terminated

Initiation date

2022-06-10

Report date

2022-07-06

Termination date

2024-05-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plainsboro, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1164-2022