Macleods Pharma Usa Inc recalls Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-1
Recalled May 11, 2022 · FDA recall D-0833-2022 · Macleods Pharma Usa
Hazard
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits · FDA Class II
Units
3216/30 count bottles; 47,904/90 count bottles; 4269/1000 count bottles = 8,676,840 tablets
Sold at
Product was distributed nationwide.
Description
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Product
Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), 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 →