Product: Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.
Reason for recall: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Recall initiated: 20250129
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated