Drug product
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.
D-0231-2025
Product summary
- Event
- Event 96194
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 70,032 bottles
- Official record key
drug-enforcement:D-0231-2025
Official wording
Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Code information: Lot Numbers: 19232368, Exp:5/2025; 19235088, Exp.: 11/2025; 19241447, Exp.: 3/2026; 19243146, Exp.: 7/2026.
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