Drug product
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.
D-0100-2026
Product summary
- Event
- Event 97797
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 172,263 bottles
- Official record key
drug-enforcement:D-0100-2026
Official wording
Reason: CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Code information: 90-count- Lot # 240721C; Exp. 02/28/2027 1000-count- Lot #230286C; Exp.02/28/2026
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso-duloxetine impurity
-
Manufacturing or process control
CGMP Deviations