Recalling firm
Sandoz Inc
Product type
Drug
Status
Ongoing
Report date
2025-09-17
Distribution
Product was distributed to one consignee in CA.
Firm state
NJ
Product quantity
1,680 bottles
Initiated by
Voluntary: Firm initiated
Reason for recall
Temperature Abuse
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
Code / lot info
Lot # VNF35A, Exp.08/31/2026
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.