Direct Rx: DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed b…
| Source | FDA · Drugs |
|---|---|
| Date | 2026-07-01 |
| Product | DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx. |
| Reason / hazard | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit |
| Classification | Class II |
| Official notice | — |
| Record ID | fda-drug:D-0617-2026 |