FDA recall D-0161-2025

Product

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.

Reason for recall

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

Distribution

Nationwide in the US

Key facts

Status

Ongoing

Initiation date

2024-12-06

Report date

2025-01-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Berlin, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0161-2025