FDAFDA · Food and drugs·Recall number D-0165-2025
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
Published January 1, 2025 · Recall initiated: December 2, 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 recommended interim limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- RemedyRepack Inc.
- Distributor
- Nationwide in the US
- Lot
- a) NDC 70518-0937-04, Lot # J0786744-061724, Exp. 06/30/2025 b) NDC 70518-0937-03, Lot # B3002625-060524, Exp. 10/31/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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