FDAFDA · Food and drugs·Recall number D-0623-2024
Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India.
Published August 7, 2024 · Recall initiated: July 23, 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
- U.S. A. Nationwide
- UPC
- 0369315308028
- Lot
- Lot#: a) 084C040, Exp 02/28/2026; b) 084A024, Exp12/31/2025.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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