DULOXETINE (DULOXETINE HYDROCHLORIDE)
Wed Dec 11 2024
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 DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ | Rising Pharma Holdings, Inc. | Nationwide. | 233,003 bottles |
| Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ | Rising Pharma Holdings, Inc. | Nationwide. | 122,925 bottles |
| Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60 | Rising Pharma Holdings, Inc. | Nationwide. | 209,376 bottles |