Drug 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
D-0567-2025
Product summary
- Firm
- Direct Rx
- Event
- Event 97251
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16 bottles
- Official record key
drug-enforcement:D-0567-2025
Official wording
Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Code information: Lot #: 02AU2406, Exp 01/31/2027
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Nitrosamine Drug Substance Related Impurity
-
Manufacturing or process control
CGMP Deviations