Nubratori, Inc: Drug Recall

Recall #D-0392-2025 · 04/15/2025

Class II: Risk

Recall Details

Recall Number
D-0392-2025
Classification
Class II
Product Type
Drug
Recalling Firm
Nubratori, Inc
Status
Ongoing
Date Initiated
04/15/2025
Location
Torrance, CA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20 boxes

Reason for Recall

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.

Product Description

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).

Distribution Pattern

PA and CA.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.