Drug recall D-0623-2024
Product
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.
Reason for recall
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.
Lots and codes
Lot#: a) 084C040, Exp 02/28/2026; b) 084A024, Exp12/31/2025.
Recall details
- Recalling firm
- FDC Limited, Aurangabad, Maharashtra State, N/A
- Quantity
- 66,528 bottles
- Distribution
- U.S. A. Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 23, 2024
Related products
- ciprofloxacin – drug information
- NDC 69315-308 ciprofloxacin · Ciprofloxacin Hydrochloride 3 mg/mL · Leading Pharma, LLC