Recall D-0242-2025

US Class II Ongoing · initiated 2025-01-29

Recalling firm

Glenmark Pharmaceuticals Inc., USA, NJ

Product

Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01.

Reason for recall

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

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