Recall Enforment Report D-1458-2019

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Macleods Pharma Usa Inc, originally initiated on 06-20-2019 for the product Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-44 The product was recalled due to cgmp deviations: impurity for n-nitroso-n-methyl-4-aminobutyric acid (nmba) detected in the active pharmaceutical ingredient (api) used to manufacture finished products.. 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-1458-2019	06-20-2019	07-17-2019	Class II	4277 bottles (4,277,000 tablets)	Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-44	CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.	Terminated
D-1457-2019	06-20-2019	07-17-2019	Class II	47520 bottles (4,276,800 tablets)	Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-10	CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.	Terminated
D-1460-2019	06-20-2019	07-17-2019	Class II	29106 bottles (2,619,540 tablets)	Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-051-10	CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.	Terminated
D-1459-2019	06-20-2019	07-17-2019	Class II	142626 bottles (12,836,340 tablets)	Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-050-10	CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.	Terminated
D-1461-2019	06-20-2019	07-17-2019	Class II	145162 bottles (13,064,580 tablets)	Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-052-10	CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.	Terminated

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
33342-044	Losartan Potassium	Losartan Potassium	Tablet, Film Coated	Oral	Macleods Pharmaceuticals Limited	Human Prescription Drug
33342-045	Losartan Potassium	Losartan Potassium	Tablet, Film Coated	Oral	Macleods Pharmaceuticals Limited	Human Prescription Drug
33342-046	Losartan Potassium	Losartan Potassium	Tablet, Film Coated	Oral	Macleods Pharmaceuticals Limited	Human Prescription Drug
33342-050	Losartan Potassium And Hydrochlorothiazide	Losartan Potassium And Hydrochlorothiazide	Tablet, Film Coated	Oral	Macleods Pharmaceuticals Limited	Human Prescription Drug
33342-051	Losartan Potassium And Hydrochlorothiazide	Losartan Potassium And Hydrochlorothiazide	Tablet, Film Coated	Oral	Macleods Pharmaceuticals Limited	Human Prescription Drug
33342-052	Losartan Potassium And Hydrochlorothiazide	Losartan Potassium And Hydrochlorothiazide	Tablet, Film Coated	Oral	Macleods Pharmaceuticals Limited	Human Prescription Drug