Drug product
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
D-0568-2024
Product summary
- Event
- Event 94639
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21,655 (30 count bottle), 34,149 (90 count bottle)
- Official record key
drug-enforcement:D-0568-2024
Official wording
Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Code information: Lot: a) GS045371, Exp: 01/31/2025; b) GS045910, Exp. 01/31/2025
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Foreign material or chemical contamination
Nitrosamine Drug Substance Related Impurity
-
Manufacturing or process control
CGMP Deviations