Drug product
Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC 51991-746-05.
D-0483-2024
Product summary
- Event
- Event 94483
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7,188/ 500 count bottles
- Official record key
drug-enforcement:D-0483-2024
Official wording
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Code information: 220456: Exp. Feb 2025
Distribution pattern: US Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso-duloxetine impurity
-
Manufacturing or process control
CGMP Deviations