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Breckenridge Pharmaceutical, Inc.: Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrell

DrugsSource: FDA (drug) · Date: 2025-12-10

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Breckenridge Pharmaceutical, Inc.
Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.
Reason / hazard
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide within the United States
Recall initiated
2025-11-24
Code info
Lot #: 240947C, 240962C, Exp. Date 04/2027
Product quantity
3397 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Berkeley Heights
State
NJ
Country
United States
Event id
98034
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