FDA recall D-0182-2025

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

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

Distribution

Nationwide

Key facts

Status

Ongoing

Initiation date

2024-12-16

Report date

2025-01-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Aurangabad, Maharashtra State, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0182-2025