PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: September 17, 2025 Initiated: August 13, 2025 #D-0626-2025

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

Reason for Recall

Temperature Abuse

Details

Recalling Firm
Sandoz Inc
Units Affected
1,680 bottles
Distribution
Product was distributed to one consignee in CA.
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Sandoz Inc. Units affected: 1,680 bottles.
Why was this product recalled?
Temperature Abuse
Which agency issued this recall?
This recall was issued by the FDA Drug on September 17, 2025. Severity: Moderate. Recall number: D-0626-2025.