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, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
Reason
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Classification
Class II
Status
Ongoing
Lot
Lot #: 240534C, Exp. Date 01/2027; 240977C, 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.