Macleods Pharma Usa Inc recalls Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-coun
Recalled May 11, 2022 · FDA recall D-0836-2022 · Macleods Pharma Usa
Hazard
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits · FDA Class II
Units
N/A
Sold at
Product was distributed nationwide.
Description
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Product
Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-count bottles (NDC # 33342-052-10) c) 1000-count bottles (NDC # 33342-052-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Manufacturer(s)
Macleods Pharma Usa Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →