Unlikely to cause harm — often a labeling or packaging issue.
Failed Dissolution Specification
| Brand name | DULOXETINE |
| Generic name | DULOXETINE |
| Active ingredient(s) | DULOXETINE HYDROCHLORIDE |
| Distributed by / for | Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States |
| NDC | 68180-295-06 |
| Full product label | 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 |
| Recalling firm | Lupin Pharmaceuticals Inc. |
| Distribution | Nationwide within the United States |
| Quantity | 111,648 units |
| Recall initiated | 2017-11-21 |
| Report date | 2017-12-06 |
| Recall completed | 2019-04-15 |
| Recall number | D-0097-2018 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Baltimore MD United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗