Drug Enforcement D-0388-2025

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Status

Ongoing

Classification

Class II

Report Date

April 30, 2025

Termination Date

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Product Information

Product description
Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922
Product quantity
343,344 bottles
Reason for recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
US Nationwide.

Location & Firm

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

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

Codes & Dates

Recall number
D-0388-2025
Event ID
96707
Recall initiation date
April 14, 2025
Center classification date
April 22, 2025
Code info
Lot # 230201C, exp. date 01/2026 230471C, exp. date 01/2026 230288C, exp. date 01/2026
More code info
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