Drug Enforcement D-0626-2025

Temperature Abuse

Status

Ongoing

Classification

Class II

Report Date

September 17, 2025

Termination Date

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Product Information

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
Product quantity
1,680 bottles
Reason for recall
Temperature Abuse
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Product was distributed to one consignee in CA.

Location & Firm

Recalling firm
Sandoz Inc
Address
100 College Rd W, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0626-2025
Event ID
97431
Recall initiation date
August 13, 2025
Center classification date
September 10, 2025
Code info
Lot # VNF35A, Exp.08/31/2026
More code info
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