Recall: D-0626-2025

Class II - Potentially Harmful

Class IIClassification

2025-08-13Initiated

OngoingStatus

Sandoz IncFirm

Product

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

Temperature Abuse

Distribution

Product was distributed to one consignee in CA.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.