Drug Enforcement D-0270-2025

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

Status

Ongoing

Classification

Class II

Report Date

March 19, 2025

Termination Date

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Product Information

Product description
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10
Product quantity
14,749 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
Nationwide

Location & Firm

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

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

Codes & Dates

Recall number
D-0270-2025
Event ID
96380
Recall initiation date
February 28, 2025
Center classification date
March 11, 2025
Code info
Lot#: 240225C, Expiration: 01/2027
More code info
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