United StatesDULOXETINE D/R 30 mg (NDC 61919-482-30, 30-count; NDC 61919-482-60, 60-count), packaged and distributed by Direct Rx and marketed as Cymbalta, lots 09JA2530 and 31JA2507 (30-count) and 09DE2412, 09JA2528, 29JA2511 (60-count), all expiring 04/30/2027, sold nationwide (263 bottles). The product was recalled because cGMP deviations resulted in the presence of N-nitroso-duloxetine impurity above the FDA’s recommended interim limit.
What's being recalled
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.
Recalling firm: Direct Rx, Dawsonville, GA, United States.
How to identify it
Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027.
The hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. Nationwide
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)