Macleods Pharma Usa Inc recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma

Recalled July 17, 2019 · FDA recall D-1459-2019 · Macleods Pharma Usa

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. · FDA Class II

Units

142626 bottles (12,836,340 tablets)

Sold at

Nationwide

Description

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

Product

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

Manufacturer(s)

Macleods Pharma Usa Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →