FDAFDA · Food and drugs·Recall number D-0099-2025
Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06
Published December 11, 2024 · Recall initiated: November 14, 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 the recommended interim limit
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Amerisource Health Services LLC
- Distributor
- PA, OH, PR
- Lot
- Lots: DT2023001A, DT2023009A, exp date Jan 31, 2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.