FDA recall D-0101-2023

Product

Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 30534, NDC 72189-0334-05

Reason for recall

cGMP deviation: discontinue of stability support for product.

Distribution

FL

Key facts

Status

Terminated

Initiation date

2022-11-02

Report date

2023-01-18

Termination date

2024-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dawsonville, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0101-2023