Product: Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain.  Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC  82009-032-10
Reason for recall: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Recall initiated: 20250725
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated