FDAFDA · Food and drugs·Recall number D-0482-2024
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Published May 15, 2024 · Recall initiated: April 29, 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
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc
- Distributor
- US Nationwide.
- Lot
- 220265: Exp. Feb 2025 220088: Exp. Nov 2024 220267: Exp. Feb 2025 220256: Exp. Feb 2025 220225: Exp. Jan 2025 220269: Exp. Feb 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.