FDAHealthApril 15, 2025
Nubratori, Inc — 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 P
⚠️ 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.
Is this relevant to me?
- Geography
- PA, CA
- Source agency
- FDA
- Category
- Health
- Published
- April 15, 2025
PA and CA.
What's affected?
- Product
- 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).
- Brand
- Nubratori, Inc
- Lot code
- C04292401X1
Additional details
Lot #: C04292401X1, BUD: 12/25/2025 (box).
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 20 boxes.
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