Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr...
FDA Recall #D-0162-2025 — Class II — December 6, 2024
Product Description
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
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
76,968 bottles
Distribution
Nationwide in the US
Code Information
Lot # 230077C, exp. date 11/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated