Recalling firm
FDC Limited
Product type
Drug
Status
Ongoing
Report date
2025-01-15
Distribution
Nationwide
Product quantity
136,181 bottles
Initiated by
Voluntary: Firm initiated
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
Product description
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
Code / lot info
Lot: 083L111, Exp. 11/30/2025; 084A032, Exp. 12/31/2025
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.