← FDA ENFORCEMENT
D-0483-2024Class II

Breckenridge Pharmaceutical, Inc

Recalling firm
Breckenridge Pharmaceutical, Inc
Product type
Drug
Status
Ongoing
Report date
2024-05-15
Distribution
US Nationwide.
Firm state
CT
Product quantity
7,188/ 500 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, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC 51991-746-05.

Code / lot info

220456: Exp. Feb 2025

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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.