Class IIReported 2025-04-30
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10
Recalled by Breckenridge Pharmaceutical, Inc
Reason for Recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Advertisement
Recall NumberD-0387-2025ClassificationClass IIStatusOngoingCategorydrugInitiated2025-04-14Reported2025-04-30DistributionUS Nationwide.Code InfoLot # 240987C, exp. date 04/2027 241014C, exp. date 04/2027Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.