PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: January 18, 2023 Initiated: November 2, 2022 #D-0101-2023

Product Description

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.

Details

Recalling Firm
Direct Rx
Units Affected
11 bottles
Distribution
FL
Location
Dawsonville, GA

Frequently Asked Questions

What product was recalled?
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. Recalled by Direct Rx. Units affected: 11 bottles.
Why was this product recalled?
cGMP deviation: discontinue of stability support for product.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 18, 2023. Severity: Moderate. Recall number: D-0101-2023.