Class IIReported 2025-02-26
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01.
Recalled by Glenmark Pharmaceuticals Inc., USA
Reason for Recall
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Advertisement
Recall NumberD-0241-2025ClassificationClass IIStatusOngoingCategorydrugInitiated2025-01-29Reported2025-02-26DistributionNationwide within the U.SCode InfoLot Numbers: 19232540, 19232524, 19232553, Exp.: 5/2025; 19240510, Exp.: 1/2026; 19241489, Exp.: 3/2026; 19243905, 19243935, Exp.: 9/2026.Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.