FDA Drug Class II — Moderate

Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-count bottles (NDC # 33342-052-10) c) 1000-count bottles (NDC # 33342-052-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

Hazard

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

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Products

Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-count bottles (NDC # 33342-052-10) c) 1000-count bottles (NDC # 33342-052-44), Rx O
Brand
Macleods Pharma Usa Inc
UPC
Lot # BLM2106B, exp. date 05/2023 BLM2101A, exp. date 01/2025 BLM2102A, exp. date 02/2023 BLM2106A, exp. date 05/2023 BLM2103B, exp. date 02/2023 BLM2104A, exp. date 05/2023 BLM2110A, exp. date 06/2023

Units Affected

N/A

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