Class IIReported 2025-02-26
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01.
Recalled by Glenmark Pharmaceuticals Inc., USA
Reason for Recall
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
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Recall NumberD-0244-2025ClassificationClass IIStatusOngoingCategorydrugInitiated2025-01-29Reported2025-02-26DistributionNationwide within the U.SCode InfoLot Numbers: 19233270, 19233278, 19233285, Exp.: 7/2025; 19233806, Exp.: 8/2025; 19240954, Exp.: 2/2026; 19241854, Exp.: 4/2026.Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.