Drug Enforcement D-0009-2025

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

Status

Completed

Classification

Class II

Report Date

October 23, 2024

Termination Date

—

Product Information

Product description
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.
Product quantity
7,107 bottles
Reason for recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Product was distributed nationwide within the United States

Location & Firm

Recalling firm
Breckenridge Pharmaceutical, Inc
Address
15 Massirio Dr Ste 201

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

Codes & Dates

Recall number
D-0009-2025
Event ID
95508
Recall initiation date
October 10, 2024
Center classification date
October 11, 2024
Code info
Lot #: 220128, Exp. Date 12/2024
More code info
—