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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