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
Check against the official notice below — it lists the full affected range.
Macleods Pharma USA Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg in bottles of 90 tablets due to the detection of an impurity called N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) in the active pharmaceutical ingredient used to manufacture the product. This represents a deviation from good manufacturing practices. The recall affects 142,626 bottles containing approximately 12.8 million tablets distributed nationwide, covering multiple lot codes manufactured between September 2019 and October 2021.
The affected lot codes are: BLK719A, BLK720A, BLK721A, BLK722A, BLK723A, BLK724A, BLK725A, BLK726A, BLK804A, BLK806A, BLK825A, and BLK826A. The source document does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Reason for recall: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. Distribution: Nationwide Quantity: 142626 bottles (12,836,340 tablets) Lot/code info: BLK719A Sep-19 BLK720A Sep-19 BLK721A Sep-19 BLK722A Sep-19 BLK723A Sep-19 BLK724A Sep-19 BLK725A Oct-19 BLK726A Oct-19 BLK804A Jan-20 BLK806A Jan-20 BLK825A Oct-21 BLK826A Oct-21
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.