FDA recall D-0009-2025

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

Distribution

Product was distributed nationwide within the United States

Key facts

Status

Completed

Initiation date

2024-10-10

Report date

2024-10-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Berlin, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0009-2025