Drug product

Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60

D-0105-2025

November 19, 2024

Class II

Product summary

Firm: Rising Pharma Holding, Inc.
Event: Event 95756
Status: Ongoing
Classification: Class II
Quantity: 209,376 bottles
Official record key: drug-enforcement:D-0105-2025

Official wording

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

Code information: a) Lot # DT2022023A, DT2022024A, DT2022025A, DT2022026A, DT2022027A, exp. date Nov-24 DT2023001B, DT2023004A, DT2023005A, DT2023006A, exp. date Jan-25

Distribution pattern: Nationwide.

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

N-nitroso-duloxetine impurity
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations