FDA Drug Class II — Moderate

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

Hazard

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Products

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.
Brand
Macleods Pharma Usa Inc
UPC
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

Units Affected

142626 bottles (12,836,340 tablets)