MedicineWatch US
Class II Recall

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
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Classification
Class II
Status
Ongoing
Lot
Lot #: 240947C, 240962C, Exp. Date 04/2027
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Breckenridge Pharmaceutical, Inc. — Class II Recall | MedicineWatch US