Drug product
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.
D-0215-2026
Product summary
- Event
- Event 98034
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3397 bottles
- Official record key
drug-enforcement:D-0215-2026
Official wording
Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Code information: Lot #: 240947C, 240962C, Exp. Date 04/2027
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso-duloxetine impurity
-
Manufacturing or process control
CGMP Deviations