Drug Enforcement D-0621-2025

CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.

Status

Ongoing

Classification

Class II

Report Date

September 17, 2025

Termination Date

—

Product Information

Product description
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC: 82009-030-10
Product quantity
3,591 bottles
Reason for recall
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
AZ, IN, NJ

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-0621-2025
Event ID
97425
Recall initiation date
August 8, 2025
Center classification date
September 8, 2025
Code info
Lot 240927C, Exp 04/30/2027
More code info
—