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.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Official details
- Category
- Drug recall
- Status
- Ongoing
- Classification
- Class II
- Company or vendor
- Direct Rx
- Affected product
- U.S. Nationwide
- Risk or reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Remedy or action
- Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027.
- Official ID
- D-0617-2026