Drug product
Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10
D-0582-2026
Product summary
- Event
- Event 99108
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 14,729 bottles.
- Official record key
drug-enforcement:D-0582-2026
Official wording
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Code information: Lot: 241180C, Exp. Date April 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