FDAFDA · Food and drugs·Recall number D-0182-2025
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05
Published January 15, 2025 · Recall initiated: December 16, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CIPROFLOXACIN
- Manufacturer
- FDC Limited
- Distributor
- Nationwide
- UPC
- 0369315308028
- Lot
- Lot: 083L111, Exp. 11/30/2025; 084A032, Exp. 12/31/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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