FDA recall D-0165-2025

Product

Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA

Reason for recall

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

Distribution

Nationwide in the US

Key facts

Status

Ongoing

Initiation date

2024-12-02

Report date

2025-01-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indiana, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0165-2025