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Recall Observatory FDA recall evidence

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

D-0626-2025

August 13, 2025

Class II

Product summary

Firm
Sandoz Inc
Event
Event 97431
Status
Ongoing
Classification
Class II
Quantity
1,680 bottles
Official record key
drug-enforcement:D-0626-2025

Official wording

Reason: Temperature Abuse

Code information: Lot # VNF35A, Exp.08/31/2026

Distribution pattern: Product was distributed to one consignee in CA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Temperature Abuse