Glenmark Pharmaceuticals Inc., USA: Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd

Hazard

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Details from the source

Reason for recall: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. Distribution: Nationwide within the U.S Quantity: 133,824 bottles Lot/code info: Lot Numbers: 19232506, 19232397, 19232415, Exp.: 5/2025; 19233791, Exp.: 8/2025; 19234248, Exp.: 9/2025; 19240909, Exp.: 2/2026; 19242598, Exp.:6/2026; 19243163, 19243122, Exp.: 7/2026; 19243884, Exp.: 9/2026.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.