HIGH

Sandoz Recalls Ciprofloxacin and Dexamethasone Otic Suspension Due to Temperature Abuse

Sandoz, Inc. recalled 1,680 bottles of Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension on August 13, 2025. The recall stems from temperature abuse that may compromise the product's efficacy. Consumers should stop using the product immediately and contact their healthcare provider or Sandoz for guidance.

Hazard Information

Temperature Abuse

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Sandoz Inc or your healthcare provider for guidance. Notification method: Letter

Product Details

The recalled product is Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, Rx only, manufactured by Novartis Manufacturing NV in Belgium. It has the NDC# 0781-6186-67 and was distributed to one consignee in California.

The Hazard

The recall is due to temperature abuse, which can affect the stability and effectiveness of the medication. This presents a high hazard level as improper storage conditions can lead to insufficient treatment.

Reported Incidents

No specific incidents of injury or adverse effects have been reported related to this recall. However, the potential for compromised treatment is a significant concern.

What to Do

Stop using the product immediately. Contact Sandoz, Inc. or your healthcare provider for further guidance. Notification will occur via letter.

Contact Information

For more information, contact Sandoz, Inc. at their customer service number or visit their official website.

Key Facts

  • Recall date: August 13, 2025
  • Distributed to one consignee in California
  • Class II recall due to temperature issues
  • Stop using the product immediately
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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot # VNF35A
Exp.08/31/2026
UPC Codes
0781-6186
0781-6186-67
Affected States
CA
Report Date
September 17, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE
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