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
Recall Number: D-1164-2022
Firm: Macleods Pharma Usa Inc
Classification: Class II
Status: Terminated
Report Date: 20220706
Initiation Date: 20220610
Termination Date: 20240523
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Product Description
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