FDA recall D-0623-2024

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 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

U.S. A. Nationwide

Key facts

Status

Ongoing

Initiation date

2024-07-23

Report date

2024-08-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Aurangabad, Maharashtra State, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0623-2024