FDA recall D-0626-2025

Sandoz Inc · Class II · drug

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 for recall

Temperature Abuse

Distribution

Product was distributed to one consignee in CA.

Key facts

Status: Ongoing
Initiation date: 2025-08-13
Report date: 2025-09-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0626-2025