Drug product

Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01.

D-0240-2025

January 29, 2025

Class II

Product summary

Firm: Glenmark Pharmaceuticals Inc., USA
Event: Event 96194
Status: Ongoing
Classification: Class II
Quantity: 133,824 bottles
Official record key: drug-enforcement:D-0240-2025

Official wording

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

Code information: 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.

Distribution pattern: Nationwide within the U.S

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

N-Nitroso Atomoxetine Impurity
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations