Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per bo
Summary
The FDA issued a Class II for Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx by Nubratori, Inc. Reason: 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.
Details
Source
Drug Recall
External ID
D-0392-2025
Action Date
2025-05-07
Status
Ongoing
Category
drug
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/Code Info: Lot #: C04292401X1, BUD: 12/25/2025 (box).
Quantity Affected: 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.
Distribution
PA and CA.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-15
Company
Torrance, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 49 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Nubratori, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Nubratori, Inc have FDA actions?
This is the only FDA action we have on record for Nubratori, Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0392-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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