DULOXETINE (DULOXETINE HYDROCHLORIDE)
Wed Mar 26 2025
1 of 14
Summary
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Product Description
| Drug | Manufacturer | Distribution Pattern | Number of Affected Units |
|---|---|---|---|
| Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99 | Rising Pharma Holdings, Inc. | Nationwide in the USA. | 1223 bottles |