RecallRadar

FDA Drug recall D-0101-2023

Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 3053…

On 2023-01-18 the FDA classified a Class II recall of Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 3053… by Direct Rx, citing cGMP deviation: discontinue of stability support for product.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0101-2023
ClassificationClass II
Statusterminated
Initiated2022-11-02
Published2023-01-18
Last updated2026-09-13 11:52 UTC
CompanyDirect Rx
DistributionFL

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

cGMP deviation: discontinue of stability support for product.

Identifiers

code_infoLot #: 07MA2232, Exp. 4/30/23

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0101-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.