RecallDepth
Class II Ongoing

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).

Company
Nubratori, Inc
Recall Initiated
April 15, 2025
Posted
May 7, 2025
Recall Number
D-0392-2025
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
20 boxes
Firm Location
Torrance, CA, United States

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.

Distribution

PA and CA.

Lot / Code Info

Lot #: C04292401X1, BUD: 12/25/2025 (box).

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