Drug product
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
D-0505-2024
Product summary
- Event
- Event 94648
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 66 bottles of 30 tablets
- Official record key
drug-enforcement:D-0505-2024
Official wording
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Code information: Lot #: J2022G, Exp: 01/01/2025
Distribution pattern: Product distributed to CA, FL, OK, KS and CT
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso-duloxetine impurity
-
Manufacturing or process control
CGMP Deviations