Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Di
Recalled October 23, 2024 · FDA recall D-0009-2025 · Breckenridge Pharmaceutical
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit · FDA Class II
Units
7,107 bottles
Sold at
Product was distributed nationwide within the United States
Description
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
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.
Manufacturer(s)
Breckenridge Pharmaceutical, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →