Drug product
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
D-0216-2026
Product summary
- Event
- Event 98034
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7389 bottles
- Official record key
drug-enforcement:D-0216-2026
Official wording
Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Code information: Lot #: 240534C, Exp. Date 01/2027; 240977C, 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