Drug product
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01.
D-0242-2025
Product summary
- Event
- Event 96194
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 53,952 bottles
- Official record key
drug-enforcement:D-0242-2025
Official wording
Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Code information: Lot Numbers: 19234630, Exp.: 10/2025; 19240529, Exp.: 1/2026.
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