DULoxetine DR USP recalled over manufacturing violations
- Recall date
- December 4, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- PD-Rx Pharmaceuticals, Inc. recalls DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, ND…
- Recall number
- D-0163-2025
- FDA classification
- Class II
- Brand / firm
- PD-Rx Pharmaceuticals, Inc.
- Sold / distributed
- Distributed within US: FL, MS, WI
Why it was recalled
CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake 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 DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
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