Duloxetine Delayed-Release Capsules USP recalled over manufacturing violations
- Recall date
- November 19, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Rising Pharma Holding, Inc. recalls Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1…
- Recall number
- D-0106-2025
- FDA classification
- Class II
- Brand / firm
- Rising Pharma Holding, Inc.
- Sold / distributed
- Nationwide.
Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
Get recall alerts
Free email alert whenever Rising Pharma Holding, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Rising Pharma Holding, Inc.