Recalling firm
FDC Limited
Product type
Drug
Status
Ongoing
Report date
2024-08-07
Distribution
U.S. A. Nationwide
Firm state
N/A
Product quantity
66,528 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, 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.
Code / lot info
Lot#: a) 084C040, Exp 02/28/2026; b) 084A024, Exp12/31/2025.
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.