Macleods Pharma Usa Inc recalls Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-1
Recalled July 6, 2022 · FDA recall D-1164-2022 · Macleods Pharma Usa
Hazard
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits · FDA Class II
Units
84/1000 count bottles
Sold at
Product was distributed nationwide.
Description
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
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
Manufacturer(s)
Macleods Pharma Usa Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →