Drug Enforcement D-0511-2025

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

Status

Ongoing

Classification

Class II

Report Date

July 16, 2025

Termination Date

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Product Information

Product description
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.
Product quantity
12,242 30-count bottles
Reason for recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Recall initiation reason
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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-0511-2025
Event ID
97179
Recall initiation date
June 30, 2025
Center classification date
July 9, 2025
Code info
Lot # 230199, Exp. Date 01/31/2026
More code info
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