FDA Drug Class II — Moderate

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

Hazard

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Products

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 US
Brand
Macleods Pharma Usa Inc
UPC
Lot # BLI2002A, exp. date 11/2022 BLI2004A, exp. date 11/2022 BLI2104B, exp. date 05/2023

Units Affected

3216/30 count bottles; 47,904/90 count bottles; 4269/1000 count bottles = 8,676,840 tablets