DULOXETINE (DULOXETINE HYDROCHLORIDE)
Wed Jan 15 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, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ | Rising Pharma Holdings, Inc. | Nationwide | 42,527 bottles |
| Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ | Rising Pharma Holdings, Inc. | Nationwide | 244,460 bottles |
| Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60 | Rising Pharma Holdings, Inc. | Nationwide | 73,680 bottles |