Recall D-0009-2025

US Class II Completed · initiated 2024-10-10

Recalling firm

Breckenridge Pharmaceutical, Inc, CT

Product

Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.

Reason for recall

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

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