Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa...
FDA Recall #D-0387-2025 — Class II — April 14, 2025
Product Description
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10
Reason for Recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed 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
16,473 bottles
Distribution
US Nationwide.
Code Information
Lot # 240987C, exp. date 04/2027 241014C, exp. date 04/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated