FDA-Drug2019-03-27Class II
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
Macleods Pharma Usa Inc
Hazard
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Sold states
NJ, NY, FL
Affected count
9695 bottles
Manufactured in
666 Plainsboro Rd, Bldg 200 Ste 230, Plainsboro, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1040-2019Don't want to check this manually?
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