Recall: D-0623-2024

Class II - Potentially Harmful

Class IIClassification

2024-07-23Initiated

OngoingStatus

FDC LimitedFirm

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

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.

Distribution

U.S. A. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.