Recalls / Class II
Class IID-0626-2025
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
- Brand name
- Ciprofloxacin And Dexamethasone
- Generic name
- Ciprofloxacin And Dexamethasone
- Active ingredients
- Ciprofloxacin Hydrochloride, Dexamethasone
- Route
- Auricular (otic)
- NDC
- 0781-6186
- FDA application
- NDA021537
- Affected lot / code info
- Lot # VNF35A, Exp.08/31/2026
Why it was recalled
Temperature Abuse
Recalling firm
- Firm
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 College Rd W, N/A, Princeton, New Jersey 08540-6604
Distribution
- Quantity
- 1,680 bottles
- Distribution pattern
- Product was distributed to one consignee in CA.
Timeline
- Recall initiated
- 2025-08-13
- FDA classified
- 2025-09-10
- Posted by FDA
- 2025-09-17
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0626-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.