Drug product
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
D-0182-2025
Product summary
- Firm
- FDC Limited
- Event
- Event 96014
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 136,181 bottles
- Official record key
drug-enforcement:D-0182-2025
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: 083L111, Exp. 11/30/2025; 084A032, Exp. 12/31/2025
Distribution pattern: 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