Drug product
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
D-0158-2025
Product summary
- Event
- Event 95953
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,815 bottles
- Official record key
drug-enforcement:D-0158-2025
Official wording
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Code information: Lots, expiry: Lot DT6022166A, exp 11/30/2024; Lot DT6023071A, exp 2/28/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso-duloxetine impurity
-
Manufacturing or process control
CGMP Deviations