FDAFDA · Food and drugs·Recall number D-0392-2025
Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per box, Preservative Free, For Iontophoresis Use Only, Non-Sterile Product, Not for Injection, NUBRATORI RX, 381 Van Ness Ave# 1507, CA 90501, NDC 71300-6564-1 (box), 71300-6564-3 (vial).
Published May 7, 2025 · Recall initiated: April 15, 2025
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
Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nubratori, Inc
- Distributor
- PA and CA.
- Lot
- Lot #: C04292401X1, BUD: 12/25/2025 (box).
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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