Product: Duloxetine Delayed-Release Capsules, USP, 30 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: 82009-030-10
Reason for recall: CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Recall initiated: 20250808
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated