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FDAFebruary 21, 2019drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.

What to do

FDA enforcement status: Terminated

Brands named

macleods pharmamacleods

UPCs

33342005210

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 — Recall Details · AllClear