Recall: D-0835-2022

Class II - Potentially Harmful

Class IIClassification

2022-04-15Initiated

TerminatedStatus

Macleods Pharma Usa IncFirm

Product

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

Reason

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

Distribution

Product was distributed nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.