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FDAApril 15, 2022drug

Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-count bottles (NDC # 33342-050-10) c) 1000-count bottles (NDC # 33342-050-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

macleods pharmamacleods

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-count bottles (NDC # 33342-050-10) c) 1000-count bottles (NDC # 33342-050-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 — Recall Details · AllClear