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Recall Enforment Report D-0833-2022

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Macleods Pharma Usa Inc, originally initiated on 04-15-2022 for the product Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 The product was recalled due to cgmp deviations- azido impurity levels observed to be above acceptable limits. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0833-202204-15-202205-11-2022Class II3216/30 count bottles; 47,904/90 count bottles; 4269/1000 count bottles = 8,676,840 tabletsLosartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limitsTerminated
D-0834-202204-15-202205-11-2022Class II3288/30 count bottles; 23,904/90 count bottles; 3364/1000 count bottles = 5,614,000 tabletsLosartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limitsTerminated
D-0832-202204-15-202205-11-2022Class II12,408/90 count bottles; 1670/1000 count bottles =2,786,720 tabletsLosartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limitsTerminated
D-0835-202204-15-202205-11-2022Class IIN/ALosartan 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 08536CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limitsTerminated
D-0837-202204-15-202205-11-2022Class IIN/ALosartan 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 08536CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limitsTerminated
D-0836-202204-15-202205-11-2022Class IIN/ALosartan 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 08536CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limitsTerminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
33342-044Losartan Potassium Losartan PotassiumTablet, Film CoatedOralMacleods Pharmaceuticals LimitedHuman Prescription Drug
33342-045Losartan Potassium Losartan PotassiumTablet, Film CoatedOralMacleods Pharmaceuticals LimitedHuman Prescription Drug
33342-046Losartan Potassium Losartan PotassiumTablet, Film CoatedOralMacleods Pharmaceuticals LimitedHuman Prescription Drug
33342-050Losartan Potassium And Hydrochlorothiazide Losartan Potassium And HydrochlorothiazideTablet, Film CoatedOralMacleods Pharmaceuticals LimitedHuman Prescription Drug
33342-051Losartan Potassium And Hydrochlorothiazide Losartan Potassium And HydrochlorothiazideTablet, Film CoatedOralMacleods Pharmaceuticals LimitedHuman Prescription Drug
33342-052Losartan Potassium And Hydrochlorothiazide Losartan Potassium And HydrochlorothiazideTablet, Film CoatedOralMacleods Pharmaceuticals LimitedHuman Prescription Drug