Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-count bottles (NDC # 33342-051-10) c) 1000-count bottles (NDC # 33342-051-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Classification
Class II
Status
Terminated
Lot
Lot # BLL2107B, exp. date 05/2023 BLL2101A, exp. date 01/2025 BLL2102A, exp. date 02/2025 BLL2103B, exp. date 02/2023 BLL2104A, exp. date 05/2023
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.