Drug Enforcement D-0212-2025

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

Status

Ongoing

Classification

Class II

Report Date

February 5, 2025

Termination Date

—

Product Information

Product description
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.
Product quantity
a) 6408 boxes and b)1488 boxes
Reason for recall
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Address
341 Mason Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0212-2025
Event ID
96105
Recall initiation date
January 13, 2025
Center classification date
January 29, 2025
Code info
Lot #: a) N01530, Exp. Date 01/2025; b) N01540, Exp. Date. 01/2025
More code info
—