Drug product

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10.

D-0308-2025

March 26, 2025

Class II

Product summary

Firm: Breckenridge Pharmaceutical, Inc.
Event: Event 96582
Status: Ongoing
Classification: Class II
Quantity: 14,863 bottles
Official record key: drug-enforcement:D-0308-2025

Official wording

Reason: CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.

Code information: Lot 240909C, Exp Date 03/31/2027

Distribution pattern: Nationwide in the US

Derived failure modes

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

Nitrosamine Drug Substance Related Impurity
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations