Drug product

Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01.

D-0238-2025

January 29, 2025

Class II

Product summary

Firm: Glenmark Pharmaceuticals Inc., USA
Event: Event 96194
Status: Ongoing
Classification: Class II
Quantity: 120,000 bottles
Official record key: drug-enforcement:D-0238-2025

Official wording

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

Code information: Lot Numbers: 19232356, Exp.: 5/2025; 19233198, Exp.: 7/2025; 19234213, 19234232, Exp.: 9/2025; 19241445, Exp.: 3/2026; 19243033, 19243121, Exp.: 7/2026.

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