Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmac...
FDA Recall #D-0009-2025 — Class II — October 10, 2024
Product Description
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Recalling Firm
Breckenridge Pharmaceutical, Inc — Berlin, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
7,107 bottles
Distribution
Product was distributed nationwide within the United States
Code Information
Lot #: 220128, Exp. Date 12/2024
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated