FDA recall D-0271-2025

Breckenridge Pharmaceutical, Inc. · Class II · drug

Product

Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05

Reason for recall

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

Distribution

Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-02-28
Report date: 2025-03-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Berkeley Heights, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0271-2025