Macleods Pharma Usa Inc recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macl
Recalled March 27, 2019 · FDA recall D-1040-2019 · Macleods Pharma Usa
Hazard
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient. · FDA Class II
Units
9695 bottles
Sold at
NJ, NY, FL
Description
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Product
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-0052-10
Manufacturer(s)
Macleods Pharma Usa Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →