D-0626-2025 Class II Ongoing

Recalled by Sandoz Inc — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
September 17, 2025
Initiation Date
August 13, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,680 bottles

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

Distribution Pattern

Product was distributed to one consignee in CA.

Code Information

Lot # VNF35A, Exp.08/31/2026