← FDA ENFORCEMENT
D-0562-2024Class II

Breckenridge Pharmaceutical, Inc

Recalling firm
Breckenridge Pharmaceutical, Inc
Product type
Drug
Status
Terminated
Report date
2024-06-26
Distribution
Nationwide in the USA
Firm state
CT
Product quantity
165,678, 90-count bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

Product description

Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-90

Code / lot info

Lot #: 230035C, Exp. date 11/30/2025; 230101C, Exp. date 12/31/2025

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.