Why it was recalled
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).
Lot numbers, UPCs & expiration codes
Lot #: C04292401X1, BUD: 12/25/2025 (box).
Where it was sold
PA and CA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0392-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 15, 2025
- FDA report date
- May 7, 2025
- Quantity
- 20 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nubratori, Inc
Original FDA data
Every field from FDA enforcement report D-0392-2025, exactly as published.
Show all FDA fields
- City
- Torrance
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 96699
- Address
- 381 Van Ness Ave Ste 1507
- Code information
- Lot #: C04292401X1, BUD: 12/25/2025 (box).
- Postal code
- 90501-7220
- Report date
- May 7, 2025
- Product type
- Drugs
- Recall number
- D-0392-2025
- Classification
- Class II
- Recalling firm
- Nubratori, Inc
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Recall initiation date
- Apr 15, 2025
- Initial firm notification
- Letter
- Center classification date
- Apr 28, 2025