Class IIReported 2025-04-30
Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922
Recalled by Breckenridge Pharmaceutical, Inc
Reason for Recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
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Recall NumberD-0388-2025ClassificationClass IIStatusOngoingCategorydrugInitiated2025-04-14Reported2025-04-30DistributionUS Nationwide.Code InfoLot # 230201C, exp. date 01/2026 230471C, exp. date 01/2026 230288C, exp. date 01/2026Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.