Recalls / Class II
Class IID-0163-2025
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
- Brand name
- Duloxetine
- Generic name
- Duloxetine Hydrochloride
- Active ingredient
- Duloxetine Hydrochloride
- Route
- Oral
- NDC
- 43063-877
- FDA application
- ANDA090778
- Affected lot / code info
- Lot # I24E77, A24E49, Exp Date: 04/30/25; J23C50, J23C97, L23B39, L23E98, Exp Date: 01/31/2025
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
Recalling firm
- Firm
- PD-Rx Pharmaceuticals, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 727 N Ann Arbor Ave, Oklahoma City, Oklahoma 73127-5822
Distribution
- Quantity
- 70, 90-count bottles
- Distribution pattern
- Distributed within US: FL, MS, WI
Timeline
- Recall initiated
- 2024-12-04
- FDA classified
- 2024-12-23
- Posted by FDA
- 2025-01-01
- Terminated
- 2025-03-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0163-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.