Macleods Pharma Usa Inc recalls Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044
Recalled May 11, 2022 · FDA recall D-0832-2022 · Macleods Pharma Usa
Hazard
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits · FDA Class II
Units
12,408/90 count bottles; 1670/1000 count bottles =2,786,720 tablets
Sold at
Product was distributed nationwide.
Description
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Product
Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), 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 →