Drug product
Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Goa 403 722 India, NDC 68180-295-06, UPC 368180295068
D-0097-2018
Product summary
- Event
- Event 78596
- Status
- Terminated
- Classification
- Class III
- Quantity
- 111,648 units
- Official record key
drug-enforcement:D-0097-2018
Official wording
Reason: Failed Dissolution Specification
Code information: Lot #: G602051, Exp. 12/2017
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specification