FDARecalled Jan 1, 2025 · #D-0163-2025
DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
Hazard
Class II — temporary health risk
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CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit Classification: Class II Distribution: Distributed within US: FL, MS, WI
Product details
- Product
- DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
- Type
- Drugs
- Manufacturer
- PD-Rx Pharmaceuticals, Inc.
- Model numbers
- I24E77
- UPCs
- —