Product: Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30
Reason for recall: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Recall initiated: 20250307
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated