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Wed Aug 20 2025
- views
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
| Drug | Manufacturer |
|---|---|
| DULOXETINE (DULOXETINE HYDROCHLORIDE) | Quallent Pharmaceuticals Health, LLC |
1,856 bottles
NJ, AZ, IN
Info not provided.
| NDC |
|---|
| 82009-029-05 |
| 82009-030-10 |
| 82009-032-10 |
| 82009-031-30 |
| 82009-031-90 |
Wed Aug 20 2025
- views
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
| Drug | Manufacturer |
|---|---|
| DULOXETINE (DULOXETINE HYDROCHLORIDE) | Quallent Pharmaceuticals Health, LLC |
1,856 bottles
NJ, AZ, IN
Info not provided.
| NDC |
|---|
| 82009-029-05 |
| 82009-030-10 |
| 82009-032-10 |
| 82009-031-30 |
| 82009-031-90 |
Wed Aug 20 2025
- views
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
| Drug | Manufacturer |
|---|---|
| DULOXETINE (DULOXETINE HYDROCHLORIDE) | Quallent Pharmaceuticals Health, LLC |
1,856 bottles
NJ, AZ, IN
Info not provided.
| NDC |
|---|
| 82009-029-05 |
| 82009-030-10 |
| 82009-032-10 |
| 82009-031-30 |
| 82009-031-90 |
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