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Recall Observatory FDA recall evidence

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

April 15, 2025

Class II

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

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing