Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmace...
FDA Recall #D-0562-2024 — Class II — May 17, 2024
Product Description
Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-90
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
165,678, 90-count bottles
Distribution
Nationwide in the USA
Code Information
Lot #: 230035C, Exp. date 11/30/2025; 230101C, Exp. date 12/31/2025
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated