Class II

Drug Recall: 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.

Breckenridge Pharmaceutical, Inc · October 10, 2024

Reason for Recall

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

Distribution

Product was distributed nationwide within the United States

States Affected

NATIONWIDE

Quantity Affected

7,107 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0009-2025

Status: completed

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