FDA recall D-0835-2022

Product

Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-count bottles (NDC # 33342-050-10) c) 1000-count bottles (NDC # 33342-050-44), 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

2022-04-15

Report date

2022-05-11

Termination date

2023-10-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plainsboro, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0835-2022