Drug 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.
D-0623-2024
Product summary
- Firm
- FDC Limited
- Event
- Event 95027
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 66,528 bottles
- Official record key
drug-enforcement:D-0623-2024
Official wording
Reason: 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.
Code information: Lot#: a) 084C040, Exp 02/28/2026; b) 084A024, Exp12/31/2025.
Distribution pattern: U.S. A. Nationwide
Derived failure modes
-
Unknown
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.