Drug product
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.
D-0233-2025
Product summary
- Event
- Event 96194
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 175,920 bottles
- Official record key
drug-enforcement:D-0233-2025
Official wording
Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Code information: Lot Numbers: 19233792, Exp.: 8/2025; 19233795, Exp.: 8/2025; 19234258, Exp.: 9/2025; 19240912, Exp.: 2/2026; 19241476, 19241477, Exp.: 3/2026; 19242599, Exp.: 6/2026; 19243163, 19243162, Exp.:7/2026;19243884, 19243887, Exp.:9/2026.
Distribution pattern: Nationwide within the U.S
Derived failure modes
-
Foreign material or chemical contamination
N-Nitroso Atomoxetine Impurity
-
Manufacturing or process control
CGMP Deviations