Drug product

Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.

D-0234-2025

January 29, 2025

Class II

Product summary

Firm: Glenmark Pharmaceuticals Inc., USA
Event: Event 96194
Status: Ongoing
Classification: Class II
Quantity: 190,320 bottles
Official record key: drug-enforcement:D-0234-2025

Official wording

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

Code information: Lot Numbers: 19234109, Exp.: 9/2025; 19234897, Exp.: 11/2025; 19240501, Exp.: 1/2026; 19241489, Exp.: 3/2026; 19241806, Exp.: 4/2026.

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