Class IIReported 2025-02-26
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.
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-0243-2025ClassificationClass IIStatusOngoingCategorydrugInitiated2025-01-29Reported2025-02-26DistributionNationwide within the U.SCode InfoLot Numbers: 19233234, 19233253, Exp.: 7/2025; 19234154, Exp.: 9/2025; 19243185, Exp.: 7/2026; 19243951, 19243974, Exp.: 9/2026.Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.