Drug product
Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06
D-0099-2025
Product summary
- Event
- Event 95849
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 37,916 bottles
- Official record key
drug-enforcement:D-0099-2025
Official wording
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Code information: Lots: DT2023001A, DT2023009A, exp date Jan 31, 2025
Distribution pattern: PA, OH, PR
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso-duloxetine impurity
-
Manufacturing or process control
CGMP Deviations