Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141,
Recalled February 26, 2025 · FDA recall D-0244-2025 · Glenmark Pharmaceuticals Inc., USA
Hazard
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. · FDA Class II
Units
58,368 bottles
Sold at
Nationwide within the U.S
Description
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Product
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01.
Manufacturer(s)
Glenmark Pharmaceuticals Inc., USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →