Ciprofloxacin and dexamethasone otic suspension recalled following temperature abuse
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, lot VNF35A, distributed by Sandoz, is recalled because of temperature abuse. 1,680 bottles went to a single consignee in California.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers precautionary recalls; the notice states only that the product experienced temperature abuse, without describing any consequence.
Plain-English summary
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, for use in ears only and available on prescription, manufactured by Novartis Manufacturing NV in Belgium and distributed by Sandoz, Inc. of Princeton, New Jersey, NDC 0781-6186-67, is being recalled. The affected product is lot VNF35A with an expiry of 08/31/2026, and the recall covers 1,680 bottles distributed to one consignee in California.
The recall was issued because of temperature abuse. The FDA classified the action as Class II. The notice does not describe a further consequence.
Patients and pharmacies holding this lot should follow the distributor's instructions for return, and patients should speak to their pharmacist about a replacement supply.
The recalled product
- Product
- CIPROFLOXACIN AND DEXAMETHASONE (CIPROFLOXACIN AND DEXAMETHASONE)
- Brand
- CIPROFLOXACIN AND DEXAMETHASONE
- Manufacturer
- Sandoz Inc
- Category
- Drug — Otic
- Affected units
- 1,680
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # VNF35A
- Exp.08/31/2026
UPCs (1)
- 0307816186677
Distribution
Distributed in 1 state:
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