Recall D-0234-2025

US Class II Ongoing · initiated 2025-01-29

Recalling firm

Glenmark Pharmaceuticals Inc., USA, NJ

Product

Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.

Reason for recall

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

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