Macleods Pharma Usa Inc recalls Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Macleods Phar

Recalled July 17, 2019 · FDA recall D-1461-2019 · 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

145162 bottles (13,064,580 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 andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-052-10

Manufacturer(s)

Macleods Pharma Usa Inc

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