FDA recall D-0568-2025

Direct Rx · Class II · drug

Product

Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,

Reason for recall

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Distribution

Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-03-07
Report date: 2025-08-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Dawsonville, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0568-2025