Drug 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.
D-0617-2026
Product summary
- Firm
- Direct Rx
- Event
- Event 99269
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 263 Bottles
- Official record key
drug-enforcement:D-0617-2026
Official wording
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Code information: Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027.
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso-duloxetine impurity
-
Manufacturing or process control
CGMP Deviations