Why it was recalled
Temperature Abuse
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
Lot numbers, UPCs & expiration codes
Lot # VNF35A, Exp.08/31/2026
Where it was sold
Product was distributed to one consignee in CA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0626-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 13, 2025
- FDA report date
- Sep 17, 2025
- Quantity
- 1,680 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Inc
Original FDA data
Every field from FDA enforcement report D-0626-2025, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97431
- Address
- 100 College Rd W
- Code information
- Lot # VNF35A, Exp.08/31/2026
- Postal code
- 08540-6604
- Report date
- Sep 17, 2025
- Product type
- Drugs
- Recall number
- D-0626-2025
- Classification
- Class II
- Recalling firm
- Sandoz Inc
- Product quantity
- 1,680 bottles
- Reason for recall
- Temperature Abuse
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed to one consignee in CA.
- Recall initiation date
- Aug 13, 2025
- Initial firm notification
- Letter
- Center classification date
- Sep 10, 2025