DULOXETINE (DULOXETINE HYDROCHLORIDE)
Wed Feb 05 2025
1 of 14
Summary
Failed Impurities/Degradation Specifications: Due to presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit of 5 ppm.
Product Description
| Drug | Manufacturer | Distribution Pattern | Number of Affected Units |
|---|---|---|---|
| Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA. | Major Pharmaceuticals | Nationwide within the United States | a) 6408 boxes and b)1488 boxes |