Drug product
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.
D-0237-2025
Product summary
- Event
- Event 96194
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 39,168 bottles
- Official record key
drug-enforcement:D-0237-2025
Official wording
Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Code information: Lot Numbers: 19234955, 19234956, Exp.: 11/2025; 19240971, Exp.: 2/2026; 19241864, Exp.: 4/2026.
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