FDAFDA · Food and drugs·Recall number D-0505-2024
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
Published May 29, 2024 · Recall initiated: May 10, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Distributor
- Product distributed to CA, FL, OK, KS and CT
- Lot
- Lot #: J2022G, Exp: 01/01/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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