Ciprofloxacin And Dexamethasone Suspension/ Drops
FDA Recall NDC 0781-6186
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Ciprofloxacin And Dexamethasone (NDC 0781-6186). A significant event, classified as Class II, was initiated on Aug 13, 2025 by Sandoz Inc. The reported reason for this action was: "Temperature Abuse"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Temperature Abuse
Aug 13, 2025
Sep 17, 2025
1,680 bottles
Recall Profile & Regulatory Data
Event ID
97431
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Sandoz Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to one consignee in CA.
Product Description
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manufacturing NV, Belgium, Distributed by: Sandoz, Inc., Princeton, NJ, NDC# 0781-6186-67, Carton NDC# 0781-6186-67
Batch or Lot Expiration Information
Lot# VNF35A, Exp.08/31/2026
Affected Packages Involved in this Recall
0781-6186-67Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
