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 for recall: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Recall initiated: 20251124
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated