Drug 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).
D-0392-2025
Product summary
- Firm
- Nubratori, Inc
- Event
- Event 96699
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20 boxes
- Official record key
drug-enforcement:D-0392-2025
Official wording
Reason: 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.
Code information: Lot #: C04292401X1, BUD: 12/25/2025 (box).
Distribution pattern: PA and CA.
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing