Status
Ongoing
Drug Enforcement D-0392-2025
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.
Classification
Class II
Report Date
May 7, 2025
Termination Date
—
Product Information
- 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).
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- PA and CA.
Location & Firm
- Recalling firm
- Nubratori, Inc
- Address
-
381 Van Ness Ave Ste 1507, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0392-2025
- Event ID
- 96699
- Recall initiation date
- April 15, 2025
- Center classification date
- April 28, 2025
- Code info
- Lot #: C04292401X1, BUD: 12/25/2025 (box).
- More code info
- —