Drug Enforcement D-0552-2025

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit

Status

Ongoing

Classification

Class II

Report Date

August 13, 2025

Termination Date

—

Product Information

Product description
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.
Product quantity
1,829 60-count bottles
Reason for recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
U.S Nationwide

Location & Firm

Recalling firm
Breckenridge Pharmaceutical, Inc.
Address
200 Connell Dr Ste 4200, N/A

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

Codes & Dates

Recall number
D-0552-2025
Event ID
97276
Recall initiation date
July 15, 2025
Center classification date
August 1, 2025
Code info
Lot: 230836C, Exp.: 02/28/2026
More code info
—