Drug product
Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC: 51991-748-90.
D-0484-2024
Product summary
- Event
- Event 94483
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 281,554/90 count bottles
- Official record key
drug-enforcement:D-0484-2024
Official wording
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Code information: 230028C: Exp. Nov 2025 230106C: Exp. Dec 2025 230170C: Exp. Dec 2025 220039: Exp. Dec 2024 220363: 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