Drug product

Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.

D-0212-2025

January 13, 2025

Class II

Product summary

Firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Event: Event 96105
Status: Terminated
Classification: Class II
Quantity: a) 6408 boxes and b)1488 boxes
Official record key: drug-enforcement:D-0212-2025

Official wording

Reason: CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit

Code information: Lot #: a) N01530, Exp. Date 01/2025; b) N01540, Exp. Date. 01/2025

Distribution pattern: Nationwide within the United States

Derived failure modes

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

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

CGMP Deviations